Software Glitch Brings Class I Recall of Mobile App for Insulin Pump

A mobile app that controls an insulin pump has been recalled for a software problem that potentially leads to crash of the app and pump battery depletion.

Tandem Diabetes Care recalled its t:connect mobile app that is used with the t:slim X2 insulin pump with Control-IQ (continuous glucose monitoring) technology. The pump is intended to deliver insulin under the skin, at set and variable rates, and can connect securely with other devices such as insulin dosing software.

The app is being recalled because the software may automatically relaunch, repeating this relaunch intermittently, which can lead to excessive Bluetooth communication, draining the pump battery and causing the pump to shut down sooner than typically expected.

Read the FDA recall notice here.

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