Tandem Diabetes Recalls Insulin Pumps Following 59 Reported Injuries

Tandem Diabetes Care, Inc., based in San Diego, has initiated a voluntary recall of its t:slim X2 insulin pumps following reports of malfunctions that have resulted in 59 injuries. The announcement, made on August 12, 2023, by the Food and Drug Administration (FDA), indicates that the recall is necessary to address a potential issue related to the device’s speaker.

Insulin pumps are essential for individuals managing diabetes, delivering insulin in predetermined doses at specific intervals. The t:slim X2 model is equipped with alarm functions to notify users of various operational concerns, including issues with insulin delivery. However, the FDA’s announcement highlighted that a specific malfunction, identified as a Malfunction 16 alarm, can interrupt insulin delivery and terminate communication with continuous glucose monitoring (CGM) devices.

Details of the Recall

The recall stems from a potential defect that could lead to an unexpected cessation of insulin delivery. This incident poses significant health risks, particularly for users who rely on consistent insulin administration to manage their blood sugar levels. In the FDA’s statement, the agency emphasized the importance of addressing this issue promptly to prevent further injuries among users.

Tandem Diabetes Care has urged customers to discontinue use of the affected insulin pumps immediately. The company is working closely with the FDA to ensure that necessary corrective actions are taken. Users of the t:slim X2 insulin pump are advised to monitor their blood sugar levels closely and consult with healthcare professionals regarding alternative insulin delivery methods while the recall is in effect.

Response and Support for Affected Users

In light of the situation, Tandem Diabetes Care is providing support to affected users, including information on how to return the recalled devices and obtain replacements. Affected individuals can reach out to the company’s customer service for assistance and advice on managing their diabetes during this period.

The incident has raised concerns within the diabetes management community regarding the reliability of medical devices. Health professionals are urging patients to remain vigilant and to report any unusual symptoms or issues with their insulin delivery systems.

As the recall progresses, both Tandem Diabetes Care and the FDA are committed to ensuring the safety and well-being of insulin pump users. The swift response highlights the importance of effective communication and regulatory oversight in the medical device industry.