Tandem’s Recalled Insulin Pump App Connected to 224 Injuries

FDA recently identified Tandem Diabetes Care’s recall of its version 2.7 of the Apple iOS t:connect mobile app used in conjunction with the t:slim X2 insulin pump with Control -IQ technology as Class I after receiving reports of 224 injuries connected to a software issue.

“This week the FDA posted a Class I recall notification for our t:connect Mobile App iOS v2.7. The t:connect Mobile App is only available in the United States,” a representative of Tandem Diabetes Care wrote in a statement to MD+DI. “The recall does not include Android app users.”

The t:connect mobile apple is an Apple iOS-based software that works with the t:slim X2 insulin pump with Control-IQ technology as a method of viewing pump information and having limited control of the pump through compatible smartphone models, operating systems, and pump software versions. The pump itself is intended to deliver insulin subcutaneously at set and variable rates for diabetes management. The Control-IQ technology works with compatible continuous glucose monitors and pumps to “adjust insulin delivery based on glucose readings, both current and predicted, and can give extra insulin as needed,” according to the FDA notice.

Tandem is specifically recalling version 2.7 of the t:connect mobile app — released Feb. 12, 2024, on iOS — by correction, not product removal, after reports that software issues may cause battery depletion of the pump. Noted software issues may cause the mobile app to crash and be automatically relaunched by the iOS operating system, which intermittently repeats and could lead to excessive Bluetooth communication. This communication may result in pump battery drain and lead to the pump shutting down sooner than typically expected.

Unexpected shutdown would cause insulin delivery to stop, potentially leading to under delivery of insulin, and in turn, hyperglycemia, or diabetic ketoacidosis. There have been 224 injuries reported and no deaths.

“Ensuring the safety of our patients is our top priority, and we take any safety concerns with our products very seriously,” the company representative wrote. “No deaths have been reported, and we will continue monitoring the new version of the t:connect app released in March to ensure the concerns described in the recent recall notice from the FDA have been addressed.”

Tandem, on March 26, sent an Urgent Medical Device Correction to affected customers requesting that the mobile app be updated to version 2.7.1 or later, which is available on the Apple App Store. The company recommended using the pump as instructed in the user guide and paying attention to all system alerts and alarms. Additionally, Tandem urged customers to closely monitor pump battery levels to ensure it is at or near full charge before going to sleep to help prevent shutdown and to carry backup supplies for insulin delivery in the case of pump failure.

“Affected customers were notified by Tandem on March 26th, and more than 98% of affected customers had already updated their devices as of April 15,” according to the company. “We continue to make every effort to contact everyone who has not yet updated their iOS app to the new version. Customers using the t:connect Mobile App on the Apple iOS platform can find more information, including how to check the version of the app they are running and how to update the app to v2.7.1, in the notification sent out to affected customers on March 26, 2024.”