FDA Warns on Insulin Pump Problem

According to MedPage Today, A mobile app used with an insulin pump that led to 224 injuries was recalled by Tandem Diabetes Care, the FDA announcedopens in a new tab or window today.

The recall is for the 2.7 version of the Apple iOS t:connect mobile app, used in conjunction with t:slim X2 insulin pump with Control-IQ technology, the agency said.

The FDA identified the action as a Class I recall, the most serious type. The recall is a correction, not a product removal, and was prompted by a software glitch that may cause the pump battery to drain sooner than expected. Users are being urged to update the app to the latest software.

"Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin," the FDA warned. As of April 15, no deaths were reported.

The defective software may cause the mobile app to crash and be automatically relaunched in the iOS operating system. This cycle may intermittently repeat, leading to excessive Bluetooth communication that could deplete the pump battery, causing the pump to shut down.

The mobile app can be used to both view pump information and control some aspects of the pump through a smartphone. It was released February 12, 2024, and was available through March 13 on the Apple iOS platform.

The pump is designed to deliver insulin subcutaneously for people with diabetes at set and variable rates. It can connect securely with other devices like insulin-dosing software.

Click here to read the full MedPage Today Article.