3 ms·

I'm not familiar with insulin dosing, but I'm guessing a sharp 10x jump should warrant my app telling me to go to the hospital? I'd expect medical devices like

I'm not familiar with insulin dosing, but I'm guessing a sharp 10x jump should warrant my app telling me to go to the hospital? I'd expect medical devices like this to have a last line of defence safety check against bugs. Basically checking all common sense edge cases like: is this dose lethal to humans, is this dose significantly more/less than historical doses, is this dose below a level in which most humans would get no benefit. These are all easily testable both in terms of software testing and regulatory testing.

Kudos 3y ago
It's a 100x dose.
bradley13 3y ago
Good software would certainly include that kind of multi-layered defense. Insulin dosage does not vary by a factor of 100. Sadly, medical software is not written any better than any other software. In this case, the firmware was probably written by engineers who don't think about possible user errors, because they are focused on the hardware. Meanwhile, the app was probably outsourced to the lowest bidder from Elbonia.
- mlsu 3y ago
  I can't speak for Omnipod in particular, but insulin pump firmware is absolutely written with user error in mind. There is probably an entire team at the company ("human factors") that will do testing to make sure that the planned UX for the device would not (or, better yet, cannot) be misinterpreted or misused. Also, other commenters here are insinuating that it's possible to wash your hands of something like this by just putting some text warning like "you should always check the dose before delivery." That is not true, neither for the FDA nor for the internal standards for the manufacturer.
wwilim 3y ago
I nearly died in my sleep 2 years ago from about 10 units unexpectedly releasing into my system from swollen tissue left behind by a broken infusion site. What the author describes is potentially lethal. The thing is, there is no such thing as a lethal dose of insulin per se. If you want to eat half a large pizza and wash it down with a can of coke, you'll likely dose 15 or more units. But dose the same amount and end up not eating your meal and you are in extremely big trouble within half an hour.
yankoff 3y ago
It's twice a dose of a large carb heavy breakfast for me. That will undoubtedly cause hypoglycemia and is very dangerous if missed.

Kudos 3y ago

It's a 100x dose.

bradley13 3y ago

Good software would certainly include that kind of multi-layered defense. Insulin dosage does not vary by a factor of 100. Sadly, medical software is not written any better than any other software. In this case, the firmware was probably written by engineers who don't think about possible user errors, because they are focused on the hardware. Meanwhile, the app was probably outsourced to the lowest bidder from Elbonia.

mlsu 3y ago
I can't speak for Omnipod in particular, but insulin pump firmware is absolutely written with user error in mind. There is probably an entire team at the company ("human factors") that will do testing to make sure that the planned UX for the device would not (or, better yet, cannot) be misinterpreted or misused. Also, other commenters here are insinuating that it's possible to wash your hands of something like this by just putting some text warning like "you should always check the dose before delivery." That is not true, neither for the FDA nor for the internal standards for the manufacturer.

wwilim 3y ago

I nearly died in my sleep 2 years ago from about 10 units unexpectedly releasing into my system from swollen tissue left behind by a broken infusion site. What the author describes is potentially lethal. The thing is, there is no such thing as a lethal dose of insulin per se. If you want to eat half a large pizza and wash it down with a can of coke, you'll likely dose 15 or more units. But dose the same amount and end up not eating your meal and you are in extremely big trouble within half an hour.

yankoff 3y ago

It's twice a dose of a large carb heavy breakfast for me. That will undoubtedly cause hypoglycemia and is very dangerous if missed.