Summary: Tandem Diabetes Care, Inc. provided an update on the March 2024 recall of its Apple iOS t:connect mobile app due to an issue causing rapid depletion of the tX2 insulin pump battery, which can lead to pump shutdown and potential under-delivery of insulin.

Key Takeaways

  • Battery Depletion Issue: The recall relates to a problem causing rapid battery depletion in the t:slim X2 insulin pump, leading to potential pump shutdowns and under-delivery of insulin.
  • Adverse Events: 107 confirmed adverse events have been reported, including two hospitalizations, but no deaths. These events were linked to high blood sugar and required medical intervention.

Tandem Diabetes Care, Inc. 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.

Battery Depletion Concerns

The 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.

Potential Risks and Adverse Events

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 tX2 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:

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

Impacted customers in the U.S. with questions about this recall can contact the Tandem Diabetes Care Technical Support Team.