Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has provided an update on the March 2024 recall of its Apple iOS t:connect mobile app in the United States. The recall was issued due to an issue causing rapid depletion of a user’s t:slim X2 insulin pump battery, leading to the pump shutting down sooner than expected. Despite the release of version 2.7.1 of the app in March, some customers have continued to experience this issue. Notices were emailed to impacted customers on August 9, 2024, with updated information and recommendations to help avoid pump battery depletion. Tandem plans to release a new version of the app to address the remaining issues and will notify all users via email and app push notifications after its release.
There have been 107 confirmed adverse events related to this recall, including confirmed high blood sugar and events requiring medical intervention. This can result in hyperglycemia or diabetic ketoacidosis, which can be life-threatening due to high blood sugar and lack of insulin. Two hospitalizations and no deaths have been reported in connection with these adverse events. Tandem strongly recommends anyone using the Apple iOS t:connect Mobile App with a t:slim X2 insulin pump to continue using their pump as prescribed in the User Guide. Users are advised to charge the pump for a short period every day, monitor battery levels closely, ensure the pump is fully charged before sleeping, and always carry backup supplies. If a low battery alert is received, users are urged to charge the device immediately.
Impacted customers in the U.S. with questions about this recall can contact the Tandem Diabetes Care Technical Support Team 24 hours a day, 7 days a week at techsupport@tandemdiabetes.com or (877) 801-6901. Tandem Diabetes Care is a global insulin delivery and diabetes technology company that manufactures and sells advanced automated insulin delivery systems, reducing the burden of diabetes management. The company’s pump portfolio includes the Tandem Mobi system and the t:slim X2 insulin pump, both featuring Control-IQ advanced hybrid closed-loop technology. Tandem Diabetes Care is headquartered in San Diego, California.
It is important for users of the t:slim X2 insulin pump with the Apple iOS t:connect Mobile App to follow the recommendations provided by Tandem to avoid battery depletion issues. Charging the pump daily, monitoring battery levels, ensuring the pump is fully charged before sleeping, and carrying backup supplies are essential steps to prevent pump shutdowns. If a low battery alert is received, immediate charging is recommended. The customer notification sent on August 9, 2024, can be accessed at tandemdiabetes.com/docs/battery-depletion.
In conclusion, Tandem Diabetes Care is actively working to address the software issue with the t:connect iOS mobile app through a future software update. The company is committed to resolving this issue to ensure the safety and well-being of its users. Customers are advised to stay informed about updates and follow the recommendations provided to prevent adverse events related to pump battery depletion. Tandem Diabetes Care remains dedicated to providing innovative diabetes management solutions and supporting patients, healthcare providers, and loved ones in managing the challenges of diabetes.
