The U.S. Food and Drug Administration has issued an urgent medical device correction for Tandem Diabetes Care's t:slim X2 insulin pump following reports of a critical malfunction that could prevent insulin delivery and lead to dangerous hyperglycemia in users.
The California-based medical device manufacturer identified an error that appears as a Malfunction 16 alarm, which can stop insulin delivery and halt communication between the insulin pump and continuous glucose monitoring (CGM) devices. The malfunction also terminates communication with the Tandem t:slim mobile app.
Significant Safety Impact
As of August 12, the FDA reported 700 confirmed adverse events related to the device error, including incidents of confirmed high blood sugar or events requiring medical intervention. Additionally, 59 injuries have been reported in connection with the malfunction, though no deaths have been documented.
The FDA warned that if the error is not addressed, it could lead to hyperglycemia due to the stoppage of insulin delivery and loss of real-time CGM Estimated Glucose Values and CGM trends. "In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional," the agency stated.
Hyperglycemia symptoms include extreme thirst, blurry vision, weakness, dry mouth, headaches, and frequent urination, according to the Centers for Disease Control and Prevention.
Device Communication and Response
Tandem Diabetes Care sent notices directly to customers across the United States between July 22 and 24, providing instructions on how to respond in the event of a Malfunction 16 alarm. The company has established a process for affected users to confirm receipt of the notice through an online form and allows customers to verify whether their specific device is at risk by looking up serial numbers on the company's website.
For users who have not yet encountered the error, Tandem recommends continuing to use the device while remaining aware of the potential issue. The company suggests enabling push notifications on the mobile app to ensure users receive alerts in case of malfunction.
Immediate Action Protocol
When a Malfunction 16 error occurs, Tandem directs customers to hit "Silence Alarm," switch to a backup method of insulin delivery as directed by their physician, and contact the company for a replacement device. Users can reach Tandem's technical support at techsupport@tandemdiabetes.com or by calling 1-877-801-6901.
Software Update in Development
The company is preparing a software update designed to address the current safety concerns by enhancing early detection of speaker failures, which appear to trigger the Malfunction 16 error. The update will also introduce persistent vibration alerts as part of the alert system to reduce potential safety risks.
Tandem Diabetes Care will notify affected pump users when the software update becomes available and will request that users complete the update promptly. The company emphasized that adverse reactions or quality problems experienced with the device may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax.
