3 ms·
Kind of surprises me that something this easy to replicate and this pervasive (200+ instances is a lot of instances when you consider the size of the user pool)
by lenerdenator 3y ago
Kind of surprises me that something this easy to replicate and this pervasive (200+ instances is a lot of instances when you consider the size of the user pool) got through the testing. Would be interested to see what the FDA makes them do as corrective action and a breakdown of how this got into production code.
- thejohnconway 3y agoI use apps for CGMs and I've gotta say, I'm not sure they are tested on anyone before they are release. They are absolute garbage.
- icegreentea2 3y agoThe corrective action is the software fix (it's already out as 2.7.1). It's the preventative action that would be interesting, but we probably won't see that. The specific recall action in the FDA database is here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206914 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res... It simply says "Software Design Change" as FDA determined root cause... so super vague. EDIT: Although the root cause might be software, it's possible that they did detect the crashing during testing, but did not characterize it fully, and/or missed a step in their risk assessment analysis to determine that it may impact battery life and therefore have risk of harm to life.
- s1artibartfast 3y agoits not 200, I think it is closer to 20,000 for battery issues. for context, there are about 200,000 formally reported events per year for pumps with alternate controllers in the US.[1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=QFG&min_report_year=2023 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tp...