connect Mobile App for iOS Devices

Tandem Diabetes Care, Inc. (Nasdaq: TNDM) today provided an update on the March 2024 recall of its Apple iOS t:connect mobile app in the United States relating to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. This battery depletion can result in the pump shutting down sooner than expected, which some customers have continued to experience following the release of version 2.7.1 of the app in March. Notices were emailed to impacted customers on August 9, 2024 with updated information and recommendations for helping avoid pump battery depletion. Tandem plans to release a new version of the app to address the remaining issues and will notify all users by email and app push notifications following its release.

Under-delivery of insulin because of a pump shutdown can result in hyperglycemia or diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugar and lack of insulin. There have been 107 confirmed adverse events with this recall. Adverse events are defined as a confirmed high blood sugar and/or an event requiring medical intervention. Two hospitalizations and no deaths have been reported.

Recommendations for Impacted t:slim X2 Pump Users

Tandem strongly recommends anyone using the Apple iOS t:connect Mobile App with a t:slim X2 insulin pump to do the following:

1. Continue using your Tandem pump and t:connect mobile app as described in the User Guide:
   1. Charge the pump for a short time every day (10 to 15 minutes) to avoid frequent full battery discharges.
   2. Monitor pump battery levels closely to ensure the pump is at or near full charge before going to sleep to help prevent pump shutdown.
   3. Always carry back-up supplies.
2. If a low battery alert is received, Tandem strongly recommends charging the device as soon as possible.

A copy of the customer notification sent on August 9, 2024 can be found at tandemdiabetes.com/docs/battery-depletion.

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 [e-mail] or [phone].

About Tandem Diabetes Care

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com.