FDA issues recall statement on insulin pump app after glitch causes more than 200 injuries

The U.S. Food and Drug Administration has issued a recall correction for an app that connects with an insulin pump due to a software issue that causes the app to crash, which can drain the battery of the insulin pump and has led to over 200 injuries.

This is a Class 1 recall, which the FDA says is the most serious type of recall, and use of the device can lead to serious injury or death.

The recall is for Version 2.7 of the t:connect mobile app, and Apple iOS-based software that works with the t:slim X2 insulin pump with Control-IQ technology. The app can also be used as a method of viewing pump information and limited control of the pump through compatible smartphone models, operating systems and pump software versions.

The recalled version of the app was distributed between Feb. 12 and March 13, 2024. The FDA has recalled 85,863 devices in the U.S.

According to the FDA, there is an issue with the app's software that can cause it to crash and be automatically relaunched by iOS. This cycle can repeat, which leads to "excessive" Bluetooth communication that can result in a pump battery drain and can lead to the pump "shutting down sooner than typically expected."

When the pump is shut down, insulin delivery is suspended, which can lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, a life-threatening condition.

The FDA said there have been 224 injuries as of April 15. No deaths have been reported.

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What to do about the recall

Tandem Diabetes Care sent all affected customers an Urgent Medical Device Correction on March 26, which requested customers to update the mobile app to version 2.7.1 or later in the Apple App Store.

Customers were also requested to complete an online form acknowledging receipt of the notice, and to continue to use the pump as described in the User Guide, paying attention to all system alerts and alarms.

They were also asked to monitor the pump battery level closely to ensure the pump is at or near full charge before going to sleep to help prevent pump shutdown, and to begin charging the device after the first low battery alert.

Users were told to always carry backup supplies for insulin delivery in case of pump failure.

How to contact Tandem Diabetes Care

Customers in the U.S. with questions can contact Tandem Diabetes Care Technical Support Team at 877-801-6901.