FDA Announces Update on Tandem Diabetes Care’s Recall of t:connect Mobile App

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WASHINGTON, D.C. — The Food and Drug Administration (FDA) has provided an important update regarding the ongoing recall of the Apple iOS t:connect mobile app by Tandem Diabetes Care, Inc. (Nasdaq: TNDM). The recall, originally issued in March 2024, addresses a critical issue causing rapid depletion of the t:slim X2 insulin pump battery. This depletion can lead to unexpected pump shutdowns, posing significant health risks to users.

The problem persists despite the release of version 2.7.1 of the app in March, with customers continuing to experience battery depletion. On August 9, 2024, Tandem Diabetes Care emailed impacted customers with updated information and recommendations to mitigate the risk. The company is actively working on a new app version to resolve the remaining issues and will inform users via email and app push notifications once it is available.

The health implications of the battery issue are severe. Under-delivery of insulin due to pump shutdown can cause hyperglycemia, a condition characterized by high blood sugar levels, and may lead to diabetic ketoacidosis, a potentially life-threatening state resulting from insufficient insulin. The FDA has confirmed 107 adverse events related to this recall, including two hospitalizations. Fortunately, no deaths have been reported.

To ensure user safety, Tandem Diabetes Care advises t:slim X2 pump users to take several precautionary measures:

  • Continue using the Tandem pump and t:connect mobile app as outlined in the User Guide.
  • Charge the pump for a brief period (10 to 15 minutes) daily to prevent frequent full battery discharges.
  • Monitor pump battery levels closely and ensure it is near full charge before sleeping to avoid shutdowns.
  • Always carry backup supplies.
  • Charge the device immediately upon receiving a low battery alert.
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The company’s Technical Support Team is available 24/7 to assist affected customers. They can be reached at techsupport@tandemdiabetes.com or (877) 801-6901.

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