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Seven diabetes patients die due to undisclosed bug in Abbott's glucose monitors

446 points by pabs3 10mo ago

gustavus 10mo ago
So my wife has a CGM and is stuck with a fancy pump that is supposed to "automatically" coordinate with her sensor to deliver or reduce insulin when it detects her numbers are too high/low. I've always been suspicious of the yahoos writing the software that controls these kinds of devices being a security guy and all. But I also would love to participate in, contribute to or help in any way with reverse engineering, open sourcing, or in some other way making it so that my wife's life isn't dependent upon the quality of software developed by the lowest bidder they could outsource it to. If anyone knows how I could help please let me know who to reach out to.
- kibbber 10mo ago
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- bdcravens 10mo ago
  There is an open source project using older pumps and somewhat older CGMs (Dexcom G6 and prior) https://openaps.org/ https://openaps.org/
  - lolc 10mo ago
    I'm using Openaps with Omnipods. Nice not having to deal with proprietary apps. Currently using Libre as sensor, luckily without their shit app. Dexcom was easier to set up.
- pastage 10mo ago
  Android APS, and xDrip. Getting watches to allow ble connection for CGMs is a great RE opportunity. It is really hard to have stable bluetooth connections.
- chews 10mo ago
  I worked at medtronic in the early 2000's (early paradigm pumps) and were evaluating wireless protocols and security... at the time we determined it was impossible to secure, once the FDA approved another device maker that did have connectivity there was a scramble to catch up. (this was palmos/pocketpc era). It was fun work but I always remembered how insanely detailed the code was, 8bit low power microcontrollers (some 16bit) but really really really tight C code. Then the demand for remote control happened and that really crapped the bed. https://www.medtronic.com/en-us/e/product-security/security-bulletins/minimed.html https://www.medtronic.com/en-us/e/product-security/security-... The amazing developer Scott Hanselman built on a PalmOS app to store readings and if I recall correctly wore 2 pumps with fast/slow insulin... he had a cybernetic pancreas in the mid-2000's.
- nimchimpsky 10mo ago
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- bsilvereagle 10mo ago
  Since you’re in security, you may enjoy this write up of decrypting the app database with glucose readings and third party API keys - https://www.frdmtoplay.com/freeing-glucose-data-from-the-freestyle-libre-3/ https://www.frdmtoplay.com/freeing-glucose-data-from-the-fre...
ivewonyoung 10mo ago
> The FDA reports that Freestyle injured over 700 people and killed seven people with this bug. Spcifically, the bug caused the device to falsely report an extremely low glucose level. Advanced stage diabetics use low reading information to inform them that they may have too much insulin currently. The usual remedy is to eat something sugary to raise glucose in the blood. Such should be done only with great care, as a false low reading can harm and even kill the patient (who eats a high-sugar-content item while glucose in the blood is, in fact, not low) I bet almost everyone with a device with that bug was injured more or less, because high blood sugar is a silent damager of many organs resulting in cumulative damage without overt short term symptoms of injury. For example, slow damage to eyesight, kidneys and nerves in the feet.
pixl97 10mo ago
>Such should be done only with great care, as a false low reading can harm and even kill the patient (who eats a high-sugar-content item while glucose in the blood is, in fact, not low). I've been a type I diabetics for over 25 years and I don't quite understand this one. Low blood sugar is an immediate life or death situation, but high blood sugar killing people? Just how high was it and for how long? As someone that has a CGM I still calibrate it by using a blood test every couple of days because the CGM sensors can wander on accuracy.
- bonsai_spool 10mo ago
  It depends on what the true blood sugar value was: if someone were already at the high end of normal and a 'brittle diabetic', you can end up in 'diabetic ketoacidosis' for T1DM individuals or—less likely—'hyperosmolar hyperglycemic state' generally. See https://www.mayoclinic.org/diseases-conditions/hyperglycemia/symptoms-causes/syc-20373631 https://www.mayoclinic.org/diseases-conditions/hyperglycemia... for a discussion of both (in Emergency conditions)
  - SkyPuncher 10mo ago
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    - slowking2 10mo ago
      You can die on the order of hours to days not of high blood sugar per se, but of the low insulin causing diabetic ketoacidosis parent comment mentions. It would be odd for a faulty sensor to cause an otherwise bad day into dka and death though. The sensor would need to be wildly off for hours and the user to not notice. Insulin delivery would need to be paused or greatly reduced for many hours. There are additional therapies like SGLT-2 that could make this more likely but they usually aren’t used with T1D precisely because they break the normally very strong correlation between inadequate insulin levels (leading to dka) and high blood glucose. Even though I can’t think of an easy way for a false low(s) to turn into lethal DKA, that doesn’t mean it didn’t happen. Abbott sells a lot of CGMs. It could have been a contributing factor to several deaths even if the fault would almost always not be a significant issue.
bdcravens 10mo ago
I depend on a pump and CGM (currently that's a Dexcom G7 and Omnipod, but I've used other brands as well). I like the technology, but you have to 1) know your own body and 2) verify if you are uncertain about the readings. Every time I've switched devices I've interacted with diabetes educators, and they pretty much always tell me to always be prepared to verify manually (with an old-school finger stick and test strips). Additionally, it's not always the fault of the technology, but often where meatspace and technology interface. When you insert a CGM, there's always a risk of the canula not going into the skin correctly. (usually it's a spring-loaded insertion tool and shoot a needle into your skin quickly, but it can mess up if the amount of pressure applied is wrong etc) In such a case, the sensor that measures your blood will often, where you can't see, sit on top of the skin. This results in insanely low readings. That happens to me a few times a year (I swap out the sensor every 10 days), and you have to listen to how your body feels relative to the readings, and replace the sensor if necessary.
- einrealist 10mo ago
  I mostly agree. I wear a Freestyle Libre. Even during their mandatory onboarding, they warn about incorrect readings for the reasons you described and urge you to verify the glucose level with manual measurements when in doubt. Also, it's better to just eat glucose when the CGM shows a rapid decline or low level, even if it's due to an inaccurate measurement. This is in contrast to accidentally applying too much insulin and forcing a low glucose level. Of course, low levels often present with very obvious symptoms. However, the FDA announcement warns about constantly low measurements. Unfortunately, the announcement does not explain what 'low' means in this context and what the actual issue was (it might be technical with the sensor or with the applicator). If it means that glucose levels are too low in terms of 'alarming low', this should prompt manual measurements. However, if the measurements show incorrect levels within the 'normal' range, this is a much bigger issue with these devices. This could explain why affected people have changed their diets or medication plans. These changes should always be discussed with a physician, though. Disease management programs can catch this (e.g. quarterly measurements of HbA1c). CGMs are helpful. But they require knowledge about their limitations, especially for people who need insulin. They helped me to bring my glucose levels back into normal range without the need for any medication. I hope, I can keep my insulin intolerance at bay for a long time this way.
rsync 10mo ago
"... wrongful death lawsuits are typically the only way to hold these companies accountable. Yet, there are very few people who have not agreed Abbott's toxic terms of their proprietary companion application ..." I (a non-diabetic interested in athletic performance) use an Abbott CGM sporadically and I have absolutely not agreed to any terms of service nor any other agreement of any kind - legal or otherwise. I bought a purpose-specific, old model iphone from "Back Market" with no SIM card, very briefly allowed it wifi access long enough to download the "Lingo" app, then set the phone to airplane mode. Dedicated, throwaway email and AppleID. It has never left airplane mode and it works perfectly. Pairing subsequent sensors does not require taking it out of airplane mode. Further, I have no legal relationship nor have I made any agreement of any kind with Abbott. I highly recommend that any user of these devices do the same.
- sallveburrpi 10mo ago
  In most cases you can’t use the device without agreeing to the terms of service right? For example a service I use a lot recently changed their terms of service - there was no way to keep using the service without agreeing. Might be different for devices or services that don’t need internet to function; but even for those you have some “activation” step nowadays that forces you to agree before “unlocking”
  - rsync 10mo ago
    "In most cases you can’t use the device without agreeing to the terms of service right?" Yeah ? Who agreed to that ToS ? Abby McAbbott ? With no phone number ? A throwaway email address ? As I said: I have not entered into any agreements of any kind with Abbott. You should not either.
    - Aurornis 10mo ago
      > Who agreed to that ToS ? Abby McAbbott ? With no phone number ? A throwaway email address ? I don’t think this matters in the way you think it does. If they can demonstrate that you have to click through the ToS to use the device and app, then the burden would be on you to show that you did not accept the ToS to use the device. But therein lies the catch: If you found a way to circumvent their setup process, you wouldn’t be using the device as designed or intended.
guerby 10mo ago
I found this video interesting on understanding what type 1 diabetic management looks like: https://www.youtube.com/watch?v=uHaYPEDGaro https://www.youtube.com/watch?v=uHaYPEDGaro Beth McNally & Amy Rush - 'TCR in Practice: Navigating Insulin for Protein & Fat in Type 1 Diabetes' At the end of the video there is some strategies described with automatic pumps. And the graph a t=174 is kind of eye opening: https://youtu.be/uHaYPEDGaro?t=174 https://youtu.be/uHaYPEDGaro?t=174
- kelseyfrog 10mo ago
  Non-diabetic who's interested in bio-feedback here. The GI graph is indeed dramatic[1]. Equally dramatic, in my experience, is the effect of exercise in modulating glucose spikes. It quickly became apparent that if I walked or worked out at the gym within 30mins of a meal, dGlucose/dt and subsequently max glucose would be dramatically reduced. Eventually, I got into the habit of planning exercise post high-GI meals as a way eliminate spikes. It was an effective weightloss strategy for me as opposed to strictly a glucose regulation method and a positive experience as a whole as I got to develop an intuitive understanding of a physiological process I had only a theoretical understanding of before. 1. It would have been nice to see a labeled abscissa[2][x-axis]. 2. https://en.wikipedia.org/wiki/Abscissa_and_ordinate https://en.wikipedia.org/wiki/Abscissa_and_ordinate
  - layla5alive 10mo ago
    +1 I do the same (and when I don't, I can feel the difference, which is generally very unpleasant).
- phasetransition 10mo ago
  Our almost 5 year old has had T1D for two years. We ended up going the way of a controlled lower carb diet for our entire family. Other than the greatly increased cost to eat this way, it has been transformative for diabetes management of our son, the amount of sleep we get, and the lessened risk of aggressive lows. We've managed to keep our sons A1C in the 6-7% window after we changed our diet to be heavily carb controlled.
jimrandomh 10mo ago
I'm a T1 diabetic, have worked on open source diabetes-tech (OpenAPS), and have used a number of different CGMs (though not this one specifically). This story... does not make very much sense. CGMs (of any brand) are not, and have never been, reliable in the way that this story implies that people want them to be reliable. The physical biology of CGMs makes that sort of reliability infeasible. Where T1s are concerned, patient education has always included the need to check with fingerstick readings sometimes, and to be aware of mismatches between sensor readings and how you're feeling. If a brand of CGMs have an issue that sometimes causes false low readings, then fixing it if it's fixable is great, but that sort of thing was very much expected, and it doesn't seem reasonable to blame it for deaths. Moreover, there are two directions in which readings can be inaccurate (false low, false high) with very asymmetric risk profiles, and the report says that the errors were in the less-dangerous direction. The FDA announcement doesn't say much about what the actual issue was, but given that it was linked to particular production batches, my bet is that it was a chemistry QC fail in one of the reagents used in the sensor wire. That's not something FOSS would be able to solve because it's not a software thing at all.
- jfengel 10mo ago
  That is odd. A too-low reading would result in less insulin and a high blood glucose, which can be extremely uncomfortable but is not immediately deadly. If it had read too high, it could result in an insulin overdose, which can indeed bring coma followed by death in fairly short order.
  - consp 10mo ago
    Theoretical you can get a hyperglycemic coma but for that to happen you need continued and sustained high blood sugar in the way your toilet would smell like a sugar factory for quite a while.
  - rzmmm 10mo ago
    In type 1 diabetes lack of insulin can lead to a condition called diabetic ketoacidosis which is deadly. In type 2 diabetes it's not usually possible.
Aurornis 10mo ago
Can anyone find the link to the document that claims 7 patients died as a result of these false low glucose readings? It’s strange that this article would go to great lengths to include footnotes and sources for various things except for the core of their claim.
- DHowett 10mo ago
  It appears to be in the fourth paragraph. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-glucose-monitor-sensor-issue-abbott-diabetes-care https://www.fda.gov/medical-devices/medical-device-recalls-a... > As of November 14, 2025, Abbott has reported 736 serious injuries, and seven deaths associated with this issue.
yegle 10mo ago
FWIW CVS did sent out a letter via USPS (I use their mail order service) about the recall and the risk. I'm not sure what the "undisclosed bug" refers to.
slwvx 10mo ago
Tidepool is a non-profit focused on diabetes. Among other things, they are working on an algorithm (loop) that does insulin dosing: https://www.tidepool.org/tidepool-loop https://www.tidepool.org/tidepool-loop If one wants to separate the hardware (insulin pump, CGM) from the algorithm that controls them, seems like Tidepool is one org to talk to.
- deleted 10mo ago
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SkyPuncher 10mo ago
I don't know how to feel about this article. On one hand, this is a very, very bad bug. On the other, the article is almost of hit job to try to prove FOSS would have solved this issue. There are also a lot of completely factually incorrect statements and wild assumptions. If my understanding is correct, the device in question, the Freestyle Libre 3, is the most popular continuous glucose monitor (GCM) in production. And, one of only a few approved GCMs available. By the very nature of being an extremely popular device that helps manage a chronic, high effort disease (diabetes management is a massive, massive mental drain) - you're going to have failures. Not to mention, I've always been under the impression that GCMs have some faults and IF the device reports do not match your expectations, you should confirm with an alternative method (like a finger prick) or seek emergency medical attention (which should have been sought in these extreme circumstances, anyways). ----- Here's the thing for me. FOSS essentially assumes that the user is going to be willing to understand the underlying details to know when FOSS fucks up. Yes, when FOSS fucks up. That's simply not realistic for any consumer product. If your argument for FOSS relies on users being able to read raw data and interpret things that are only learned by education, that's not a consumer grade solution. Anecdotally, I used use Abbott's Lingo CGM a few months ago to help get me more data on a health issue I was having. I would never, ever, in my wildest dreams have trusted FOSS to get this right. There's simply too much money/effort/rigor involved in getting these biomedical devices correct to believe that the FOSS community could simply create a better product without actually doing any trials or studies. Not to mention, the recommended app (Juggluco) has a terrible UI. This just isn't going anywhere. To be clear, this is a deadly bug and Abbott should be held accountable - but claiming the solution is some untested, untrailed, terrible UX is not the answer.
- altairprime 10mo ago
  In the context of FOSS adherents in general, the belief is that a rising tide lifts all boats: that the work of one dedicated open source hobbyist auditing CGM code for flaws would benefit all CGM users one way or another, if I apply that general principle here as a specific example. However, the characteristic of shoddy UX is loosely correlated with how much the developer(s) choose to (and can afford to) spend developing their work, not with whether the work is open or closed source. The exact balance shifts over time based on cultural-economic shifts in both developer capability (“what’s a folder? does left-click mean I have to use my left hand?”) and in free time energy (“I did so many hours at work to afford rent/food next week that I have no energy left to care about PRs”). In any case, I agree that the post falls quite flat at being effective advocacy here; to me, not because it clamors for “terrible UX”, but because it fails to make a case that the author’s desired FOSS outcome holds any value at all for those who don’t know or care about source code. It’s certainly a horror story but I’m quite inured to horror as a sales tactic, and that’s where it drops the ball.
rKarpinski 10mo ago
"Globally, Abbott has received reports of 736 severe adverse events (57 in the U.S.) and seven deaths (none in the U.S.) potentially associated with this issue."[1] [1] https://abbott.mediaroom.com/press-releases?item=124718 https://abbott.mediaroom.com/press-releases?item=124718
- Aurornis 10mo ago
  Thanks. That’s very different than the headline claim that the issue killed 7 patients. The “associated with” is a broad term in cases like this that means the device may have been used at the time, not that the bug specifically caused the death.
  - wccrawford 10mo ago
    It's worse than that. "potentially associated with". That's a far stretch from "killed".
phasetransition 10mo ago
Diabetes for the unfamiliar, in plain language: 1. Insulin helps get sugar into cells. Glucagon gets stored sugar out of the liver into the blood. Diabetes management in 2025 only deals with supplying external insulin. 2. There are several variants of diabetes. Type 1 is an autoimmune disorder where the body attacks the cells that make insulin. 3. Too much insulin equals all the sugar getting sucked out of your blood and lymph and into cells. This is really bad in an acute way. Your brain cannot run without sugar. Accidentally give yourself too much insulin for the sugars and wind up dead or in a coma in short order. 4. Highs are also bad, but generally in a less acute way. There are exceptions, but being too high with blood glucose for a period of time doesn't have the acute risks of being too low. Diabetics (or their caregivers) carry around quick absorbing sugar sources to help against a low. 5. The peak action (fastest reduction in blood glucose level) of the common insulin, in the way we dose it, peaks 90 - 120 minutes after the dose. The long tail is about 5 total hours of action from the point of dosing. So you should give insulin in advance of when you expect digestion to move glucose into your bloodstream. This is tricky. Also, as insulin ages, the peak of the action happens later. If a new vial is 90 minutes, an nearly empty vial might be 120 minutes after dosing for peak action. 6. CGMs, the on-body instrument in question here, are both flakey and amazing. There's a novel of good and bad here. I'm glad they exist, they can be cantankerous. They are a tiny potentiostat, if that is something you happen to be familiar with. 7. Very high blood sugar is treated with extra insulin to overcome the osmotic pressure of having too much glucose in the bloodstream. There's also a lot of chemistry here (glycocalyx to get you started). If your blood sugar is high you generally need more insulin to get past the hysteresis effects. Once the blood sugar starts to come down, that extra insulin is still around, and can cause a dramatic low. CGMs let you observe this, and "catch the low" by eating sugar to replenish the baseline sugar trapped in circulation. 8. Diabetes management is challenge every day, multiple times a day. Especially with small child who doesn't communicate to you about what they believe about their blood sugar. This is my personal circumstance. 9. Endocrinologists have suggested some wild stuff to my wife and I. For instance, keep a tube of cake icing around, as you can administer it rectally to a child who is passed out (or worse) from a deep low blood glucose. This is how poor the standard of care can be. Father of 4.5 YO son with Type 1 diabetes, and materials engineer by education.
- 10mo ago
phyzome 10mo ago
Strong claim in headline ("die due to") that is not substantiated by the FDA report.
cynicalsecurity 10mo ago
There is no such thing as "diabetes", people should start distinguishing between type 1 diabetes and type 2 diabetes - they are different diseases. Type 1 diabetes is an autoimmune disease with no cure, not caused by food, lifestyle or weight, and is an absolute living hell; while type 2 diabetes is caused by excessive weight and can sometimes be put into remission or even fully cured through weight loss. Learn about type 1 diabetes to understand why this distinction matters. Type 1 diabetes is not caused by food or weight. It results from an autoimmune reaction that completely destroys insulin-producing beta cells. No one understands what causes type 1 diabetes, but generally it's believed to be caused by viruses and infections. Sometimes you can read about "genetic factor", but overall majority of people with type 1 diabetes have no family history of this disease. The incidence of type 1 diabetes has been increasing in many countries, and researchers do not yet understand why. It most often appears in children and young adults and currently has no cure. Once again: type 1 diabetes appears to be random and has no cure. It's not caused by food or weight in the slightest. And your life (of life of your child and yours too) suddenly becomes an absolute living hell. Think about it for a second. For some unknown reason public awareness of type 1 diabetes is hugely limited compared with other incurable diseases. For example, in the UK more people live with type 1 diabetes than with HIV, yet until someone is directly affected, they usually know nothing about this disease. It hits them like a train.
- dredmorbius 10mo ago
  By the same logic, there's no such thing as "cancer", a "cold" (or more accurately: upper respiritory illness), or a broken leg, since each of these have many distinct causes. All models are wrong, some models are useful. And some are based in at least part on historical accident and sequence of understanding. Diabetes (etymology, Greek diabetes, excessive discharge of urine), is one such of these. Of the multiple distinct types of diabetes currently recognised (types 1 & 2, which you note, gestational, MODY, 5, and possibly several others), there is a commonality of primary symptoms (unregulated, often high, blood sugar), treatments (most must or may be treated with supplemental insulin), monitoring (of blood glucose levels typically by finger stick or CGM, as well as HgA1C for longer-term status and progression), of healthcare providers specialising in the diseases (generally endocrinologists), and of long-term complications: high blood pressure, heart disease and failure, neuropathy, poor circulation, various infections, and often peripheral limb amputations. Thus the medical literature notes that diabetes is a group of common endocrine diseases all sharing high blood sugar levels, though of distinct types having distinct causes but largely similar treatments. In the same sense, treatment for a broken leg largely doesn't distinguish on the cause of the fracture (blunt trauma, falls, osteoperosis, gunshot), treatment of respiratory illnesses is similar despite different infectious agents, and cancers, whilst varying greatly in prognosis and treatment, share the commonality of unregulated growth and metastases, with similar end-stage consequences. All labels and concepts are human constructs to simplify a complex world. Absolutism over definitions tends not to be especially enlightening. Or useful.
user_7832 10mo ago
I understand that low BG is typically much more capable at making itself fatal than high BGs (T1 myself, like half the people in this thread.) > > Abbott Diabetes Care stated that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. My understanding is the problem is probably the same, or likely related to, the pressure low - where basically if you eg lie down on the side of the sensor, it can produce a false low sugar reading. Presumably, this could push some (already sick) people towards DKA. DKA can go from "slightly bad" to "crazy bad" in a span of hours. (Don't, or do ask me how I know.) Add in reluctance of people to go to the hospital in the US, and I can totally see how people might've died because of it. It's a bit of a swiss cheeshole/perfect storm - poor BG management, likely not well enough to afford a hospital, possibly already sick - and unfortunately I'd imagine economically struggling people are likely to have a significant overlap of many of these at the same time. Tragic, but realistic, given the sheer scale of many people use these devices.
tordrt 10mo ago
I might have experienced one of these deadly bugs, although I got way to high measurements, not too low. I bought one of these monitors for fun, because I wanted to see how my blood sugar reacts to different foods. The freestyle libre 3 plus. After wearing it for some time I woke up one morning to sky high blood sugar, talking 13+mmol/l. My manual measures showed around 4.9mmol/l. The device was essentially not functioning anymore. I sent the company an email, filed out a report, returned the device and received a new one in the mail.
- pixl97 10mo ago
  There is another post here stating a German article saying 'false highs' which is a whole lot more dangerous than false lows. This can cause people to overcorrect and go low. This said, the same CGM should have warned about the low. As always if your expected blood sugar isn't matching up with measured sugar levels do a finger stick as recommended by the manufacturer. There are a lot of potential device to human interface issues that can happen.
deleted 10mo ago
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0xbadcafebee 10mo ago
> Would FOSS Have Saved Patients' Lives? FOSS can be written the same as any other software, and there's plenty of FOSS that fails to meet modern best practices. But a software building code might have saved lives. The same way building codes save lives around the world every day, by ensuring safety-critical things in the world aren't slapped together haphazardly, and are tested for safety. Ask your representatives in government to assemble a professional body to set software building codes for the software that could potentially kill you.
stranded22 10mo ago
What the f is ‘early stage’ and ‘advance staged’ diabetic? My wife is a T1D - you’re either diabetic or not. Freestyles are not reliable to be used purely for managing immediate levels of glucose - it is more about trends and give an idea of whether it is going up or down. This appears to be an education issue, for the users and also for the writer.
- Wolfenstein98k 10mo ago
  Type 2, most likely. It changes for people as it progresses. But even Type 1 people will have a different experience in the early days versus years later - you don't lose all beta cell function in one moment.
ysleepy 10mo ago
Oddly the notification brief in germany specifies false-high glucose readings, which would explain the urgency of the problem much better. For high glucose you inject insulin, but if you don't really have high glucose you end up with dangerously low levels leading to coma or death. https://www.bfarm.de/SharedDocs/Kundeninfos/DE/10/2025/42777-25_kundeninfo_de.pdf?__blob=publicationFile https://www.bfarm.de/SharedDocs/Kundeninfos/DE/10/2025/42777...
- rzmmm 10mo ago
  That sounds more sensible. I was thinking maybe the error caused DKA due to pumps suspending all insulin overnight or something.
Halan 10mo ago
Always fingerpick test if the monitor throws a number you don’t feel. Any diabetic person must have heard and read this recommendation a thousand times. The actual scenario to worry about is if the number is too high and a close loop system make so the pump injects too much insulin.
raverbashing 10mo ago
Let's not fool ourselves in thinking open source would solve this problem here And I'm glad the text agrees > It's hubris for activists to guarantee that harm would be prevented if Freestyle had publicly released the hardware specifications and the complete, corresponding source code (CCS). FOSS isn't immune to bugs — even dangerous ones > We also will probably never know whether this issue was in hardware or software That being said > Specifically, the bug caused the device to falsely report an extremely low glucose level Aren't people cross-checking this with how they're feeling? People on low glucose won't be feeling normal. If you really had an abnormally low reading maybe double check with a strip meter and calibrate with how you feel Medical devices are hard. There are hundreds of variables causing variations in measurement > As a public policy and public health matter, the public deserves to know the technical details (software and hardware) of both the functioning device and the failed device Yes. 100% this (I'm all for OSS for reading calibrated data and processing it the way you prefer of course)
croemer 10mo ago
> As of November 14, 2025, Abbott has reported 736 serious injuries, and seven deaths associated with this issue. It's a stretch to go from "associated with 7 deaths" to "killed 7 people". These devices are worn by millions. So coincidental deaths will happen irrespective of causality. Would be good to have more details on the cases. Kind of hard to see how low readings would cause deaths. You eat, then notice things don't go up, then do a finger stick test and notice it's off. To die you'd have to end up with ketoacidosis - there are ways to notice. Sure it's bad to have falsely low values but very unlikely to kill.
ggfdh 10mo ago
Bugs are going to happen in any software project. I’m more concerned that their QA missed the issue. Seems like they should’ve had some inkling given how easy it is to test blood glucose.
dazc 10mo ago
At the time of my diagnosis for Type 1 my glucose levels were very high (HbA1c of 134 (UK) / 14% (US)). I lost an extreme amount of weight over a short time period and became very ill. I'm struggling to understand how occasional false low monitor readings would cause any significant problems?
z3ratul163071 10mo ago
open source medical devices is a tricky thing. medical devices are heavily regulated for a reason. what individual in their right mind would contribute to a medical device software that has huge liability risk if people are injured or killed?
realitydrift 10mo ago
[flagged]
sgf0568 10mo ago
Abbott states that only the Freestyle Libre 3 and 3 Plus are affected. However, I use the Libre 2 Plus with my Tandem t:slim pump, and since March of this year I have contacted Abbott at least ten times because the CGM consistently reports low blood glucose when a fingerstick reading is actually 20–30 percent higher. These inaccurate readings cause my pump to reduce or completely suspend insulin delivery. As a result, my most recent A1C was 7.1, even though the pump software calculated it should have been 6.3 based on the CGM data being fed into the system. While 7.1 is not too terrible, I have not been above 7.0 in many years. You might ask why I don’t switch to Dexcom to see if it performs better. Unfortunately, with my insurance coverage, Dexcom would cost nearly seven times more per month.

446 points by pabs3 10mo ago

So my wife has a CGM and is stuck with a fancy pump that is supposed to "automatically" coordinate with her sensor to deliver or reduce insulin when it detects her numbers are too high/low. I've always been suspicious of the yahoos writing the software that controls these kinds of devices being a security guy and all. But I also would love to participate in, contribute to or help in any way with reverse engineering, open sourcing, or in some other way making it so that my wife's life isn't dependent upon the quality of software developed by the lowest bidder they could outsource it to. If anyone knows how I could help please let me know who to reach out to.

kibbber 10mo ago
[dead]
bdcravens 10mo ago
There is an open source project using older pumps and somewhat older CGMs (Dexcom G6 and prior) https://openaps.org/ https://openaps.org/
- lolc 10mo ago
  I'm using Openaps with Omnipods. Nice not having to deal with proprietary apps. Currently using Libre as sensor, luckily without their shit app. Dexcom was easier to set up.
pastage 10mo ago
Android APS, and xDrip. Getting watches to allow ble connection for CGMs is a great RE opportunity. It is really hard to have stable bluetooth connections.
chews 10mo ago
I worked at medtronic in the early 2000's (early paradigm pumps) and were evaluating wireless protocols and security... at the time we determined it was impossible to secure, once the FDA approved another device maker that did have connectivity there was a scramble to catch up. (this was palmos/pocketpc era). It was fun work but I always remembered how insanely detailed the code was, 8bit low power microcontrollers (some 16bit) but really really really tight C code. Then the demand for remote control happened and that really crapped the bed. https://www.medtronic.com/en-us/e/product-security/security-bulletins/minimed.html https://www.medtronic.com/en-us/e/product-security/security-... The amazing developer Scott Hanselman built on a PalmOS app to store readings and if I recall correctly wore 2 pumps with fast/slow insulin... he had a cybernetic pancreas in the mid-2000's.
nimchimpsky 10mo ago
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bsilvereagle 10mo ago
Since you’re in security, you may enjoy this write up of decrypting the app database with glucose readings and third party API keys - https://www.frdmtoplay.com/freeing-glucose-data-from-the-freestyle-libre-3/ https://www.frdmtoplay.com/freeing-glucose-data-from-the-fre...

ivewonyoung 10mo ago

> The FDA reports that Freestyle injured over 700 people and killed seven people with this bug. Spcifically, the bug caused the device to falsely report an extremely low glucose level. Advanced stage diabetics use low reading information to inform them that they may have too much insulin currently. The usual remedy is to eat something sugary to raise glucose in the blood. Such should be done only with great care, as a false low reading can harm and even kill the patient (who eats a high-sugar-content item while glucose in the blood is, in fact, not low) I bet almost everyone with a device with that bug was injured more or less, because high blood sugar is a silent damager of many organs resulting in cumulative damage without overt short term symptoms of injury. For example, slow damage to eyesight, kidneys and nerves in the feet.

pixl97 10mo ago

>Such should be done only with great care, as a false low reading can harm and even kill the patient (who eats a high-sugar-content item while glucose in the blood is, in fact, not low). I've been a type I diabetics for over 25 years and I don't quite understand this one. Low blood sugar is an immediate life or death situation, but high blood sugar killing people? Just how high was it and for how long? As someone that has a CGM I still calibrate it by using a blood test every couple of days because the CGM sensors can wander on accuracy.

bonsai_spool 10mo ago
It depends on what the true blood sugar value was: if someone were already at the high end of normal and a 'brittle diabetic', you can end up in 'diabetic ketoacidosis' for T1DM individuals or—less likely—'hyperosmolar hyperglycemic state' generally. See https://www.mayoclinic.org/diseases-conditions/hyperglycemia/symptoms-causes/syc-20373631 https://www.mayoclinic.org/diseases-conditions/hyperglycemia... for a discussion of both (in Emergency conditions)
- SkyPuncher 10mo ago
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  - slowking2 10mo ago
    You can die on the order of hours to days not of high blood sugar per se, but of the low insulin causing diabetic ketoacidosis parent comment mentions. It would be odd for a faulty sensor to cause an otherwise bad day into dka and death though. The sensor would need to be wildly off for hours and the user to not notice. Insulin delivery would need to be paused or greatly reduced for many hours. There are additional therapies like SGLT-2 that could make this more likely but they usually aren’t used with T1D precisely because they break the normally very strong correlation between inadequate insulin levels (leading to dka) and high blood glucose. Even though I can’t think of an easy way for a false low(s) to turn into lethal DKA, that doesn’t mean it didn’t happen. Abbott sells a lot of CGMs. It could have been a contributing factor to several deaths even if the fault would almost always not be a significant issue.

bdcravens 10mo ago

I depend on a pump and CGM (currently that's a Dexcom G7 and Omnipod, but I've used other brands as well). I like the technology, but you have to 1) know your own body and 2) verify if you are uncertain about the readings. Every time I've switched devices I've interacted with diabetes educators, and they pretty much always tell me to always be prepared to verify manually (with an old-school finger stick and test strips). Additionally, it's not always the fault of the technology, but often where meatspace and technology interface. When you insert a CGM, there's always a risk of the canula not going into the skin correctly. (usually it's a spring-loaded insertion tool and shoot a needle into your skin quickly, but it can mess up if the amount of pressure applied is wrong etc) In such a case, the sensor that measures your blood will often, where you can't see, sit on top of the skin. This results in insanely low readings. That happens to me a few times a year (I swap out the sensor every 10 days), and you have to listen to how your body feels relative to the readings, and replace the sensor if necessary.

einrealist 10mo ago
I mostly agree. I wear a Freestyle Libre. Even during their mandatory onboarding, they warn about incorrect readings for the reasons you described and urge you to verify the glucose level with manual measurements when in doubt. Also, it's better to just eat glucose when the CGM shows a rapid decline or low level, even if it's due to an inaccurate measurement. This is in contrast to accidentally applying too much insulin and forcing a low glucose level. Of course, low levels often present with very obvious symptoms. However, the FDA announcement warns about constantly low measurements. Unfortunately, the announcement does not explain what 'low' means in this context and what the actual issue was (it might be technical with the sensor or with the applicator). If it means that glucose levels are too low in terms of 'alarming low', this should prompt manual measurements. However, if the measurements show incorrect levels within the 'normal' range, this is a much bigger issue with these devices. This could explain why affected people have changed their diets or medication plans. These changes should always be discussed with a physician, though. Disease management programs can catch this (e.g. quarterly measurements of HbA1c). CGMs are helpful. But they require knowledge about their limitations, especially for people who need insulin. They helped me to bring my glucose levels back into normal range without the need for any medication. I hope, I can keep my insulin intolerance at bay for a long time this way.

rsync 10mo ago

"... wrongful death lawsuits are typically the only way to hold these companies accountable. Yet, there are very few people who have not agreed Abbott's toxic terms of their proprietary companion application ..." I (a non-diabetic interested in athletic performance) use an Abbott CGM sporadically and I have absolutely not agreed to any terms of service nor any other agreement of any kind - legal or otherwise. I bought a purpose-specific, old model iphone from "Back Market" with no SIM card, very briefly allowed it wifi access long enough to download the "Lingo" app, then set the phone to airplane mode. Dedicated, throwaway email and AppleID. It has never left airplane mode and it works perfectly. Pairing subsequent sensors does not require taking it out of airplane mode. Further, I have no legal relationship nor have I made any agreement of any kind with Abbott. I highly recommend that any user of these devices do the same.

sallveburrpi 10mo ago
In most cases you can’t use the device without agreeing to the terms of service right? For example a service I use a lot recently changed their terms of service - there was no way to keep using the service without agreeing. Might be different for devices or services that don’t need internet to function; but even for those you have some “activation” step nowadays that forces you to agree before “unlocking”
- rsync 10mo ago
  "In most cases you can’t use the device without agreeing to the terms of service right?" Yeah ? Who agreed to that ToS ? Abby McAbbott ? With no phone number ? A throwaway email address ? As I said: I have not entered into any agreements of any kind with Abbott. You should not either.
  - Aurornis 10mo ago
    > Who agreed to that ToS ? Abby McAbbott ? With no phone number ? A throwaway email address ? I don’t think this matters in the way you think it does. If they can demonstrate that you have to click through the ToS to use the device and app, then the burden would be on you to show that you did not accept the ToS to use the device. But therein lies the catch: If you found a way to circumvent their setup process, you wouldn’t be using the device as designed or intended.

guerby 10mo ago

I found this video interesting on understanding what type 1 diabetic management looks like: https://www.youtube.com/watch?v=uHaYPEDGaro https://www.youtube.com/watch?v=uHaYPEDGaro Beth McNally & Amy Rush - 'TCR in Practice: Navigating Insulin for Protein & Fat in Type 1 Diabetes' At the end of the video there is some strategies described with automatic pumps. And the graph a t=174 is kind of eye opening: https://youtu.be/uHaYPEDGaro?t=174 https://youtu.be/uHaYPEDGaro?t=174

kelseyfrog 10mo ago
Non-diabetic who's interested in bio-feedback here. The GI graph is indeed dramatic[1]. Equally dramatic, in my experience, is the effect of exercise in modulating glucose spikes. It quickly became apparent that if I walked or worked out at the gym within 30mins of a meal, dGlucose/dt and subsequently max glucose would be dramatically reduced. Eventually, I got into the habit of planning exercise post high-GI meals as a way eliminate spikes. It was an effective weightloss strategy for me as opposed to strictly a glucose regulation method and a positive experience as a whole as I got to develop an intuitive understanding of a physiological process I had only a theoretical understanding of before. 1. It would have been nice to see a labeled abscissa[2][x-axis]. 2. https://en.wikipedia.org/wiki/Abscissa_and_ordinate https://en.wikipedia.org/wiki/Abscissa_and_ordinate
- layla5alive 10mo ago
  +1 I do the same (and when I don't, I can feel the difference, which is generally very unpleasant).
phasetransition 10mo ago
Our almost 5 year old has had T1D for two years. We ended up going the way of a controlled lower carb diet for our entire family. Other than the greatly increased cost to eat this way, it has been transformative for diabetes management of our son, the amount of sleep we get, and the lessened risk of aggressive lows. We've managed to keep our sons A1C in the 6-7% window after we changed our diet to be heavily carb controlled.

jimrandomh 10mo ago

I'm a T1 diabetic, have worked on open source diabetes-tech (OpenAPS), and have used a number of different CGMs (though not this one specifically). This story... does not make very much sense. CGMs (of any brand) are not, and have never been, reliable in the way that this story implies that people want them to be reliable. The physical biology of CGMs makes that sort of reliability infeasible. Where T1s are concerned, patient education has always included the need to check with fingerstick readings sometimes, and to be aware of mismatches between sensor readings and how you're feeling. If a brand of CGMs have an issue that sometimes causes false low readings, then fixing it if it's fixable is great, but that sort of thing was very much expected, and it doesn't seem reasonable to blame it for deaths. Moreover, there are two directions in which readings can be inaccurate (false low, false high) with very asymmetric risk profiles, and the report says that the errors were in the less-dangerous direction. The FDA announcement doesn't say much about what the actual issue was, but given that it was linked to particular production batches, my bet is that it was a chemistry QC fail in one of the reagents used in the sensor wire. That's not something FOSS would be able to solve because it's not a software thing at all.

jfengel 10mo ago
That is odd. A too-low reading would result in less insulin and a high blood glucose, which can be extremely uncomfortable but is not immediately deadly. If it had read too high, it could result in an insulin overdose, which can indeed bring coma followed by death in fairly short order.
- consp 10mo ago
  Theoretical you can get a hyperglycemic coma but for that to happen you need continued and sustained high blood sugar in the way your toilet would smell like a sugar factory for quite a while.
- rzmmm 10mo ago
  In type 1 diabetes lack of insulin can lead to a condition called diabetic ketoacidosis which is deadly. In type 2 diabetes it's not usually possible.

Aurornis 10mo ago

Can anyone find the link to the document that claims 7 patients died as a result of these false low glucose readings? It’s strange that this article would go to great lengths to include footnotes and sources for various things except for the core of their claim.

DHowett 10mo ago
It appears to be in the fourth paragraph. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-glucose-monitor-sensor-issue-abbott-diabetes-care https://www.fda.gov/medical-devices/medical-device-recalls-a... > As of November 14, 2025, Abbott has reported 736 serious injuries, and seven deaths associated with this issue.

yegle 10mo ago

FWIW CVS did sent out a letter via USPS (I use their mail order service) about the recall and the risk. I'm not sure what the "undisclosed bug" refers to.

slwvx 10mo ago

Tidepool is a non-profit focused on diabetes. Among other things, they are working on an algorithm (loop) that does insulin dosing: https://www.tidepool.org/tidepool-loop https://www.tidepool.org/tidepool-loop If one wants to separate the hardware (insulin pump, CGM) from the algorithm that controls them, seems like Tidepool is one org to talk to.

deleted 10mo ago
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SkyPuncher 10mo ago

I don't know how to feel about this article. On one hand, this is a very, very bad bug. On the other, the article is almost of hit job to try to prove FOSS would have solved this issue. There are also a lot of completely factually incorrect statements and wild assumptions. If my understanding is correct, the device in question, the Freestyle Libre 3, is the most popular continuous glucose monitor (GCM) in production. And, one of only a few approved GCMs available. By the very nature of being an extremely popular device that helps manage a chronic, high effort disease (diabetes management is a massive, massive mental drain) - you're going to have failures. Not to mention, I've always been under the impression that GCMs have some faults and IF the device reports do not match your expectations, you should confirm with an alternative method (like a finger prick) or seek emergency medical attention (which should have been sought in these extreme circumstances, anyways). ----- Here's the thing for me. FOSS essentially assumes that the user is going to be willing to understand the underlying details to know when FOSS fucks up. Yes, when FOSS fucks up. That's simply not realistic for any consumer product. If your argument for FOSS relies on users being able to read raw data and interpret things that are only learned by education, that's not a consumer grade solution. Anecdotally, I used use Abbott's Lingo CGM a few months ago to help get me more data on a health issue I was having. I would never, ever, in my wildest dreams have trusted FOSS to get this right. There's simply too much money/effort/rigor involved in getting these biomedical devices correct to believe that the FOSS community could simply create a better product without actually doing any trials or studies. Not to mention, the recommended app (Juggluco) has a terrible UI. This just isn't going anywhere. To be clear, this is a deadly bug and Abbott should be held accountable - but claiming the solution is some untested, untrailed, terrible UX is not the answer.

altairprime 10mo ago
In the context of FOSS adherents in general, the belief is that a rising tide lifts all boats: that the work of one dedicated open source hobbyist auditing CGM code for flaws would benefit all CGM users one way or another, if I apply that general principle here as a specific example. However, the characteristic of shoddy UX is loosely correlated with how much the developer(s) choose to (and can afford to) spend developing their work, not with whether the work is open or closed source. The exact balance shifts over time based on cultural-economic shifts in both developer capability (“what’s a folder? does left-click mean I have to use my left hand?”) and in free time energy (“I did so many hours at work to afford rent/food next week that I have no energy left to care about PRs”). In any case, I agree that the post falls quite flat at being effective advocacy here; to me, not because it clamors for “terrible UX”, but because it fails to make a case that the author’s desired FOSS outcome holds any value at all for those who don’t know or care about source code. It’s certainly a horror story but I’m quite inured to horror as a sales tactic, and that’s where it drops the ball.

rKarpinski 10mo ago

"Globally, Abbott has received reports of 736 severe adverse events (57 in the U.S.) and seven deaths (none in the U.S.) potentially associated with this issue."[1] [1] https://abbott.mediaroom.com/press-releases?item=124718 https://abbott.mediaroom.com/press-releases?item=124718

Aurornis 10mo ago
Thanks. That’s very different than the headline claim that the issue killed 7 patients. The “associated with” is a broad term in cases like this that means the device may have been used at the time, not that the bug specifically caused the death.
- wccrawford 10mo ago
  It's worse than that. "potentially associated with". That's a far stretch from "killed".

phasetransition 10mo ago

Diabetes for the unfamiliar, in plain language: 1. Insulin helps get sugar into cells. Glucagon gets stored sugar out of the liver into the blood. Diabetes management in 2025 only deals with supplying external insulin. 2. There are several variants of diabetes. Type 1 is an autoimmune disorder where the body attacks the cells that make insulin. 3. Too much insulin equals all the sugar getting sucked out of your blood and lymph and into cells. This is really bad in an acute way. Your brain cannot run without sugar. Accidentally give yourself too much insulin for the sugars and wind up dead or in a coma in short order. 4. Highs are also bad, but generally in a less acute way. There are exceptions, but being too high with blood glucose for a period of time doesn't have the acute risks of being too low. Diabetics (or their caregivers) carry around quick absorbing sugar sources to help against a low. 5. The peak action (fastest reduction in blood glucose level) of the common insulin, in the way we dose it, peaks 90 - 120 minutes after the dose. The long tail is about 5 total hours of action from the point of dosing. So you should give insulin in advance of when you expect digestion to move glucose into your bloodstream. This is tricky. Also, as insulin ages, the peak of the action happens later. If a new vial is 90 minutes, an nearly empty vial might be 120 minutes after dosing for peak action. 6. CGMs, the on-body instrument in question here, are both flakey and amazing. There's a novel of good and bad here. I'm glad they exist, they can be cantankerous. They are a tiny potentiostat, if that is something you happen to be familiar with. 7. Very high blood sugar is treated with extra insulin to overcome the osmotic pressure of having too much glucose in the bloodstream. There's also a lot of chemistry here (glycocalyx to get you started). If your blood sugar is high you generally need more insulin to get past the hysteresis effects. Once the blood sugar starts to come down, that extra insulin is still around, and can cause a dramatic low. CGMs let you observe this, and "catch the low" by eating sugar to replenish the baseline sugar trapped in circulation. 8. Diabetes management is challenge every day, multiple times a day. Especially with small child who doesn't communicate to you about what they believe about their blood sugar. This is my personal circumstance. 9. Endocrinologists have suggested some wild stuff to my wife and I. For instance, keep a tube of cake icing around, as you can administer it rectally to a child who is passed out (or worse) from a deep low blood glucose. This is how poor the standard of care can be. Father of 4.5 YO son with Type 1 diabetes, and materials engineer by education.

10mo ago

phyzome 10mo ago

Strong claim in headline ("die due to") that is not substantiated by the FDA report.

cynicalsecurity 10mo ago

There is no such thing as "diabetes", people should start distinguishing between type 1 diabetes and type 2 diabetes - they are different diseases. Type 1 diabetes is an autoimmune disease with no cure, not caused by food, lifestyle or weight, and is an absolute living hell; while type 2 diabetes is caused by excessive weight and can sometimes be put into remission or even fully cured through weight loss. Learn about type 1 diabetes to understand why this distinction matters. Type 1 diabetes is not caused by food or weight. It results from an autoimmune reaction that completely destroys insulin-producing beta cells. No one understands what causes type 1 diabetes, but generally it's believed to be caused by viruses and infections. Sometimes you can read about "genetic factor", but overall majority of people with type 1 diabetes have no family history of this disease. The incidence of type 1 diabetes has been increasing in many countries, and researchers do not yet understand why. It most often appears in children and young adults and currently has no cure. Once again: type 1 diabetes appears to be random and has no cure. It's not caused by food or weight in the slightest. And your life (of life of your child and yours too) suddenly becomes an absolute living hell. Think about it for a second. For some unknown reason public awareness of type 1 diabetes is hugely limited compared with other incurable diseases. For example, in the UK more people live with type 1 diabetes than with HIV, yet until someone is directly affected, they usually know nothing about this disease. It hits them like a train.

dredmorbius 10mo ago
By the same logic, there's no such thing as "cancer", a "cold" (or more accurately: upper respiritory illness), or a broken leg, since each of these have many distinct causes. All models are wrong, some models are useful. And some are based in at least part on historical accident and sequence of understanding. Diabetes (etymology, Greek diabetes, excessive discharge of urine), is one such of these. Of the multiple distinct types of diabetes currently recognised (types 1 & 2, which you note, gestational, MODY, 5, and possibly several others), there is a commonality of primary symptoms (unregulated, often high, blood sugar), treatments (most must or may be treated with supplemental insulin), monitoring (of blood glucose levels typically by finger stick or CGM, as well as HgA1C for longer-term status and progression), of healthcare providers specialising in the diseases (generally endocrinologists), and of long-term complications: high blood pressure, heart disease and failure, neuropathy, poor circulation, various infections, and often peripheral limb amputations. Thus the medical literature notes that diabetes is a group of common endocrine diseases all sharing high blood sugar levels, though of distinct types having distinct causes but largely similar treatments. In the same sense, treatment for a broken leg largely doesn't distinguish on the cause of the fracture (blunt trauma, falls, osteoperosis, gunshot), treatment of respiratory illnesses is similar despite different infectious agents, and cancers, whilst varying greatly in prognosis and treatment, share the commonality of unregulated growth and metastases, with similar end-stage consequences. All labels and concepts are human constructs to simplify a complex world. Absolutism over definitions tends not to be especially enlightening. Or useful.

user_7832 10mo ago

I understand that low BG is typically much more capable at making itself fatal than high BGs (T1 myself, like half the people in this thread.) > > Abbott Diabetes Care stated that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. My understanding is the problem is probably the same, or likely related to, the pressure low - where basically if you eg lie down on the side of the sensor, it can produce a false low sugar reading. Presumably, this could push some (already sick) people towards DKA. DKA can go from "slightly bad" to "crazy bad" in a span of hours. (Don't, or do ask me how I know.) Add in reluctance of people to go to the hospital in the US, and I can totally see how people might've died because of it. It's a bit of a swiss cheeshole/perfect storm - poor BG management, likely not well enough to afford a hospital, possibly already sick - and unfortunately I'd imagine economically struggling people are likely to have a significant overlap of many of these at the same time. Tragic, but realistic, given the sheer scale of many people use these devices.

tordrt 10mo ago

I might have experienced one of these deadly bugs, although I got way to high measurements, not too low. I bought one of these monitors for fun, because I wanted to see how my blood sugar reacts to different foods. The freestyle libre 3 plus. After wearing it for some time I woke up one morning to sky high blood sugar, talking 13+mmol/l. My manual measures showed around 4.9mmol/l. The device was essentially not functioning anymore. I sent the company an email, filed out a report, returned the device and received a new one in the mail.

pixl97 10mo ago
There is another post here stating a German article saying 'false highs' which is a whole lot more dangerous than false lows. This can cause people to overcorrect and go low. This said, the same CGM should have warned about the low. As always if your expected blood sugar isn't matching up with measured sugar levels do a finger stick as recommended by the manufacturer. There are a lot of potential device to human interface issues that can happen.

deleted 10mo ago

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0xbadcafebee 10mo ago

> Would FOSS Have Saved Patients' Lives? FOSS can be written the same as any other software, and there's plenty of FOSS that fails to meet modern best practices. But a software building code might have saved lives. The same way building codes save lives around the world every day, by ensuring safety-critical things in the world aren't slapped together haphazardly, and are tested for safety. Ask your representatives in government to assemble a professional body to set software building codes for the software that could potentially kill you.

stranded22 10mo ago

What the f is ‘early stage’ and ‘advance staged’ diabetic? My wife is a T1D - you’re either diabetic or not. Freestyles are not reliable to be used purely for managing immediate levels of glucose - it is more about trends and give an idea of whether it is going up or down. This appears to be an education issue, for the users and also for the writer.

Wolfenstein98k 10mo ago
Type 2, most likely. It changes for people as it progresses. But even Type 1 people will have a different experience in the early days versus years later - you don't lose all beta cell function in one moment.

ysleepy 10mo ago

Oddly the notification brief in germany specifies false-high glucose readings, which would explain the urgency of the problem much better. For high glucose you inject insulin, but if you don't really have high glucose you end up with dangerously low levels leading to coma or death. https://www.bfarm.de/SharedDocs/Kundeninfos/DE/10/2025/42777-25_kundeninfo_de.pdf?__blob=publicationFile https://www.bfarm.de/SharedDocs/Kundeninfos/DE/10/2025/42777...

rzmmm 10mo ago
That sounds more sensible. I was thinking maybe the error caused DKA due to pumps suspending all insulin overnight or something.

Halan 10mo ago

Always fingerpick test if the monitor throws a number you don’t feel. Any diabetic person must have heard and read this recommendation a thousand times. The actual scenario to worry about is if the number is too high and a close loop system make so the pump injects too much insulin.

raverbashing 10mo ago

Let's not fool ourselves in thinking open source would solve this problem here And I'm glad the text agrees > It's hubris for activists to guarantee that harm would be prevented if Freestyle had publicly released the hardware specifications and the complete, corresponding source code (CCS). FOSS isn't immune to bugs — even dangerous ones > We also will probably never know whether this issue was in hardware or software That being said > Specifically, the bug caused the device to falsely report an extremely low glucose level Aren't people cross-checking this with how they're feeling? People on low glucose won't be feeling normal. If you really had an abnormally low reading maybe double check with a strip meter and calibrate with how you feel Medical devices are hard. There are hundreds of variables causing variations in measurement > As a public policy and public health matter, the public deserves to know the technical details (software and hardware) of both the functioning device and the failed device Yes. 100% this (I'm all for OSS for reading calibrated data and processing it the way you prefer of course)

croemer 10mo ago

> As of November 14, 2025, Abbott has reported 736 serious injuries, and seven deaths associated with this issue. It's a stretch to go from "associated with 7 deaths" to "killed 7 people". These devices are worn by millions. So coincidental deaths will happen irrespective of causality. Would be good to have more details on the cases. Kind of hard to see how low readings would cause deaths. You eat, then notice things don't go up, then do a finger stick test and notice it's off. To die you'd have to end up with ketoacidosis - there are ways to notice. Sure it's bad to have falsely low values but very unlikely to kill.

ggfdh 10mo ago

Bugs are going to happen in any software project. I’m more concerned that their QA missed the issue. Seems like they should’ve had some inkling given how easy it is to test blood glucose.

dazc 10mo ago

At the time of my diagnosis for Type 1 my glucose levels were very high (HbA1c of 134 (UK) / 14% (US)). I lost an extreme amount of weight over a short time period and became very ill. I'm struggling to understand how occasional false low monitor readings would cause any significant problems?

z3ratul163071 10mo ago

open source medical devices is a tricky thing. medical devices are heavily regulated for a reason. what individual in their right mind would contribute to a medical device software that has huge liability risk if people are injured or killed?

realitydrift 10mo ago

[flagged]

sgf0568 10mo ago

Abbott states that only the Freestyle Libre 3 and 3 Plus are affected. However, I use the Libre 2 Plus with my Tandem t:slim pump, and since March of this year I have contacted Abbott at least ten times because the CGM consistently reports low blood glucose when a fingerstick reading is actually 20–30 percent higher. These inaccurate readings cause my pump to reduce or completely suspend insulin delivery. As a result, my most recent A1C was 7.1, even though the pump software calculated it should have been 6.3 based on the CGM data being fed into the system. While 7.1 is not too terrible, I have not been above 7.0 in many years. You might ask why I don’t switch to Dexcom to see if it performs better. Unfortunately, with my insurance coverage, Dexcom would cost nearly seven times more per month.