FDA announces most severe recall for insulin pump-linked iOS app

The FDA has issued a Class I recall for the t:connect Mobile App iOS v2.7, which is used in conjunction with the t:slim X2 insulin pump with Control-IQ technology. This recall was prompted by a software issue that may cause the app to crash and be automatically relaunched, potentially leading to pump battery drain and premature pump shutdown. The FDA warns that this could result in an under-delivery of insulin, leading to hyperglycemia or even diabetic ketoacidosis, which can be life-threatening. Therefore, it is recommended that individuals with diabetes who use insulin pumps carry backup supplies in case of pump failure.

Tandem Diabetes Care, the company behind the t:connect app, has addressed the issue by releasing an app update for the Apple iOS platform (v2.7.1) on March 18th. They have also notified affected customers and report that more than 98% of them have already updated their devices as of April 15th. The company continues to make efforts to contact those who have not yet updated. They provide detailed instructions for customers to check their mobile app versions and ensure that they are using the updated version to avoid any potential risks.

As of April 15th, there have been 224 reported injuries related to the software issue with the t:connect app. However, there have been no reported deaths associated with this recall. Tandem Diabetes Care reassures customers that they take safety concerns seriously and are committed to ensuring the safety of their patients. They are closely monitoring the new version of the app to ensure that the concerns raised by the FDA recall notice have been adequately addressed.

It is crucial for individuals who use the t:connect mobile app with the t:slim X2 insulin pump to update their app to the latest version to avoid any potential risks associated with the software issue. By following the instructions provided by Tandem Diabetes Care, users can ensure that their app is up to date and functioning correctly. Additionally, carrying backup supplies in case of pump failure is recommended by the FDA to prevent any complications from insulin delivery issues.

The FDA’s Class I recall highlights the importance of monitoring and addressing safety concerns with medical devices and apps used in healthcare settings. This incident serves as a reminder of the potential risks associated with using technology in healthcare and the importance of prompt action to address any issues that may arise. By staying vigilant and following manufacturer recommendations for updates and maintenance, individuals can help ensure their safety and well-being when using medical devices and apps for managing chronic conditions like diabetes.

Tandem Diabetes Care’s swift response to the software issue with the t:connect app demonstrates their commitment to patient safety and their dedication to addressing any potential risks promptly and effectively. By releasing an updated version of the app and notifying affected customers, they have taken steps to mitigate the impact of the recall and prevent any further harm to individuals using their products. Moving forward, continued monitoring and communication with customers will be essential to maintaining trust and ensuring the safe use of their devices.