The U.S. Food and Drug Administration (FDA) recently announced a Class I recall, the highest level of severity, for a mobile application connected to an insulin pump. The app, the t:connect Mobile App iOS v2.7 by Tandem Diabetes Care, was recalled due to a software bug affecting its communication with the t:slim X2 insulin pump.
This flaw could potentially place diabetes patients, who rely on the app to control their insulin levels, at severe health risk. The FDA advises patients to stop using the affected app version for now and revert to using the insulin pump’s in-built user interface until the issue is resolved.
Tandem Diabetes Care is already moving on addressing this problem and is expected to release a corrective software update shortly. Meanwhile, users have been encouraged to keep a close watch on their glucose levels and consult with their healthcare professionals about managing their insulin.
This application, meant to sync with the t:slim X2 insulin pump incorporated with Control-IQ technology, has been observed to abruptly stop and restart. This could potentially lead to rapid battery exhaustion in the pump, and users may not access or control their t:slim X2 pump via the app. In this case, interruptions to insulin delivery may happen, posing severe health concerns for patients dependent on the pump.
Addressing Tandem’s insulin app software issue
Therefore, swift attention to this issue is essential to ensure users’ safety.
The company has been in contact with affected users and is actively working on a solution. Conversely, users are recommended to manually monitor their insulin pumps regularly to prevent any unexpected incidents.
The FDA advises backup supplies for those relying on insulin pumps, due to the possible risk of insulin shortage during serious occurrences. This can lead to dangerous health conditions such as hyperglycemia or diabetic ketoacidosis. Additionally, patients are counseled to work closely with healthcare providers to develop emergency plans, increasing blood sugar testing frequency and maintaining an adequate supply of glucose tablets for emergencies.
Upon receiving the recall notice, Tandem Diabetes Care started working on the recommended software modifications and updated the t:connect app on March 18. By April 15, over 98% of impacted users had updated their devices. While there have been 224 reported injuries due to this issue, no fatalities have occurred. The situation remains under close observation to ensure the updated app resolves the outlined problems.
