Sam Brusco, Associate Editor05.08.24
Tandem Diabetes Care’s recall of Version 2.7 of the Apple iOS t:connect mobile app used with its t:slim X2 insulin pump with Control-IQ technology has been labeled Class I by the U.S. Food and Drug Administration (FDA).
The company is recalling version 2.7, which was released February 12 on the iOs platform, of the app for the t:slim X2 pump by a correction, not product removal. The company identified a software issue that can cause the mobile app to crash and be automatically relaunched by iOs.
The cycle repeats intermittently, leading to excessive Bluetooth communication that can cause pump battery drain and it shutting down sooner than expected. This will suspend insulin delivery which can result in high blood sugar or even diabetic ketoacidosis, Tandem warned.
The company has received reports of 224 injuries as of April 15, with no reports of death.
Tandem’s March 26 Urgent Medical Device Correction urged customers to update the mobile app to version 2.7.1 or later in the Apple App Store. Customers were also recommended to pay attention to all system alerts and alarms, and monitor battery level closely to make sure the pump is at or near full charge before going to sleep.
The app can also be used to view pump information and have limited pump control through compatible smartphone models, operating systems, and pump software versions.
The t:slim X2 insulin pump is intended to deliver insulin under the skin (subcutaneous delivery), at set and variable rates, for the management of diabetes in persons requiring insulin. It can connect securely with other devices like insulin dosing software. 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.
The company is recalling version 2.7, which was released February 12 on the iOs platform, of the app for the t:slim X2 pump by a correction, not product removal. The company identified a software issue that can cause the mobile app to crash and be automatically relaunched by iOs.
The cycle repeats intermittently, leading to excessive Bluetooth communication that can cause pump battery drain and it shutting down sooner than expected. This will suspend insulin delivery which can result in high blood sugar or even diabetic ketoacidosis, Tandem warned.
The company has received reports of 224 injuries as of April 15, with no reports of death.
Tandem’s March 26 Urgent Medical Device Correction urged customers to update the mobile app to version 2.7.1 or later in the Apple App Store. Customers were also recommended to pay attention to all system alerts and alarms, and monitor battery level closely to make sure the pump is at or near full charge before going to sleep.
More about the recalled device
The recalled t:connect mobile app is an Apple iOS-based software and is for Version 2.7 of the mobile app. The t:connect mobile app works with the t:slim X2 insulin pump with Control-IQ technology.The app can also be used to view pump information and have limited pump control through compatible smartphone models, operating systems, and pump software versions.
The t:slim X2 insulin pump is intended to deliver insulin under the skin (subcutaneous delivery), at set and variable rates, for the management of diabetes in persons requiring insulin. It can connect securely with other devices like insulin dosing software. 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.