FDA recalls popular diabetes care app after glitches result in injuries to 224 patients

The glitches drained the pump battery, causing premature shutdown and risking the user's life by suspending insulin delivery.
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Posted at 7:47 PM, May 09, 2024

A glitch in a version of Tandem Diabetes Care's Apple iOS app that is used with certain insulin pumps has led to over 200 injuries, prompting the U.S. Food and Drug Administration to issue a recall.

The FDA says the recall is for the t:connect mobile app, version 2.7, which operates on Apple iOS and it's used with the t:slim X2 insulin pump that features Control-IQ technology.

The app allows users to view the pump’s information and control it with a smartphone, while the pump administers insulin under the skin, adjusting delivery based on glucose readings, and can provide additional insulin as needed using the Control-IQ technology, the FDA explains.

However, the 2.7 version of the app for Apple, released in February of this year, has a software problem that causes the app to crash and restart repeatedly, draining the pump’s battery and causing it to shut down early.

The FDA explained that this caused the pumps to stop delivering the proper amount of insulin to the patients, possibly leading to high blood-sugar levels or even diabetic ketoacidosis, a serious and life-threatening condition.

While the FDA has not reported any deaths, as of April 15 there had been 224 injuries reported.

Tandem Diabetes Care has contacted all those affected and urges users to update their app to version 2.7.1 or later.