Friday, May 10, 2024

FDA Recalls Defective Insulin Pump App

Jess Weatherbed (Hacker News):

At least 224 people with diabetes have reported injuries linked to a defective iOS app that caused their insulin pumps to shut down prematurely, according to the US Food and Drug Administration (FDA).

On Wednesday, the agency announced that California-based medical device manufacturer Tandem Diabetes Care has issued a recall for version 2.7 of the iOS t:connect mobile app, which is used in conjunction with the company’s t:slim X2 insulin pump. Specifically, the recall relates to a software issue that can cause the app to repeatedly crash and relaunch, resulting in the pump’s battery being drained by excessive Bluetooth communication.

This is an interesting failure mode that was probably not contemplated when designing and testing the app. I also wonder to what extent quality control decreases as more and more products become subsumed by smartphones. When everything is an app that’s in theory easy to update, how carefully does anyone check that a given version is solid?

I’m also fascinated by the idea of FDA recalling an app. What does that even mean when the bug was already fixed back in March? They can’t remove the bad version of the app from the store shelves. Yet it took until May to essentially issue a government press release telling customers to update the app?

I wonder what effect that will have given that most iOS users probably already had automatic updates enabled or heard from the company itself more than a month ago.

Lastly, if ever there were a time that the release notes should accurately describe the benefits of an update, this was it. Yet all the App Store says for version 2.7.1 of the t:connect app is “Overall app performance updates.”

Mariella Moon:

If a pump shuts down without warning and before the user expects it to, it could lead to the under-delivery of insulin. As the FDA explained in its recall, that could result in hyperglycemia and even diabetic ketoacidosis, a life-threatening complication caused by the inability of the body to turn sugar into energy due to the lack of insulin. Tandem Diabetes Care, the company behind the app and the pump, sent all affected customers an emergency notice back in March. It advised them to update their app, to monitor their pump battery level closely and to carry backup insulin supplies.

Via Corentin Cras-Méneur:

We’ve been hit by the issue. The pump was draining really fast. It’s supposed to have been addressed in an update since but lately, the battery drain has been a bit faster than I would have expected…


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Corentin Cras-Méneur

For what it’s worth, I asked to Tandem again today and they recommended updating the app in version 2.7.1, then you should unpair the iPhone and Pump (both from the app and from the pump UI), forget the devices from both sides, then re-pair it all. We’ll see if that helps.
My understanding is that the app crashes, the relaunches, reconnects through bluetooth, and again, and again, draining the battery.

In any case, it highlights that despite extensive testing and a long tedious FDA approval process, bugs can still pass through, and on a device as critical as an insulin pump, the consequences can be severe…

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