Tandem Diabetes Care, Inc. announced a voluntary medical device correction for select t:slim X2 insulin pumps due to a potential speaker-related issue. This issue can trigger a Malfunction 16 alarm, which results in the discontinuation of insulin delivery and terminates communication between the pump and the continuous glucose monitoring (CGM) device. If unaddressed, this could lead to hyperglycemia, potentially requiring hospitalization or medical intervention.
The company reported 700 confirmed adverse events, defined as confirmed high blood sugar and/or events requiring medical intervention, and 59 reported injuries related to this issue. No deaths have been reported. Tandem sent notices directly to impacted customers in the United States between July 22 and 24, 2025, providing instructions on how to respond to a Malfunction 16.
The U.S. Food and Drug Administration and international regulatory agencies have been notified of this action. Tandem plans to release a software update designed to enhance early detection of speaker failure and introduce persistent vibration alerts to mitigate potential safety risks. The company will notify all pump users when this software update becomes available.
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