Hopefully this is just the one sternly-worded letter they are required to issue and they won’t actually take any action on this, but posting here for awareness.
Article on statement:
https://www.bloomberg.com/news/articles/2019-05-17/patient-hurt-by-do-it-yourself-pancreas-prompting-fda-warning
Actual FDA statement:
https://www.fda.gov/medical-devices/safety-communications/fda-warns-people-diabetes-and-health-care-providers-against-use-devices-diabetes-management-not
Hah… F them…
As if people only using the “approved” therapies don’t have “insulin overdoses” sometimes…
Idiotic. I despise the FDA, and I’m not even interested in looping… but certainly hope they don’t manage to screw it up for those who are. Gee here’s an idea… if they’re so concerned about people making their own APs, why don’t they actually approve one that works with Dexcom themselves so people don’t have to cobble together their own systems out of desperation…
Katie DiSimone wrote an exceptionally good description/analysis of the underlying incident that lead to the FDA warning, and conclusions to be drawn from it.
http://seemycgm.com/2019/05/20/fda-warning-against-diy-systems/
What a wonderful article! The next one on testing wasn’t bad either. Thanks for sharing.
Thanks for the detail/background. Very helpful.
The FDA’s reasoning was actually fairly reassuring and valuable. It essentially was an adverse event report, which is to be expected.
The biggest problem, as usual, was what the media did with it.