FDA recalls defective iOS app that injured over 200 insulin pump users

Unrecognizable woman with type-1 diabetes holds her smartphone in one hand and insulin pump in the other.
An updated version of the iOS app is available that should resolve the issue for impacted Tandem Diabetes Care customers. | Photo Illustration by Matt Harbicht/Getty Images for Tandem Diabetes Care

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 battery drain can cause the pump to shut down “earlier than typically expected” according to Tandem,…

Continue reading…