FDA Warns on Insulin Pump Problem

A mobile app used with an insulin pump that led to 224 injuries was recalled by Tandem Diabetes Care, the FDA announced 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.

The recall applies to 85,863 devices in the U.S.

On March 26, Tandem alerted customers and healthcare providers using this system to update to mobile app version 2.7.1 or later (available in the Apple store) and to monitor pump battery level closely. Users should charge their device soon after the first low battery alert and carry backup supplies for insulin delivery in case the pump fails, the company said.

Cleared in December 2019, the t:slim X2 insulin pump was the first interoperable insulin pump on the market, meaning it can be integrated with multiple continuous glucose monitor sensors. It is available by prescription only and indicated for use with NovoLog or Humalog U-100 insulin.

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