The US Food and Drug Administration (FDA) has reported that at least 224 people with diabetes have experienced injuries due to a defective iOS app that caused their insulin pumps to shut down prematurely. California-based medical device manufacturer Tandem Diabetes Care has issued a recall for version 2.7 of the iOS t:connect mobile app, used with the t:slim X2 insulin pump. The recall is related to a software issue causing the app to repeatedly crash and relaunch, draining the pump’s battery with excessive Bluetooth communication. The company has advised customers to update to version 2.7.1 or later to resolve the issue.
The FDA considers this a Class I recall, the most serious type, due to the potential for serious injuries or death. The pump’s shutdown will suspend insulin delivery, leading to under-delivery of insulin and potentially causing hyperglycemia, including severe cases that could lead to diabetic ketoacidosis. While no deaths have been reported as of April 15th, Tandem has warned users to be extra cautious, especially during sleep when it’s easier to miss battery depletion warnings. Customers impacted by the recall are urged to confirm they have been notified through an online form provided by the company, and to reach out directly with any questions or concerns.
Tandem Diabetes Care has emphasized the importance of addressing the insulin pump recall promptly to avoid potential health risks associated with the software issue. Customers are advised to update their iOS t:connect mobile app to version 2.7.1 or later to prevent the pump from shutting down prematurely due to excessive Bluetooth communication draining the battery. The company’s proactive response to the issue, along with ongoing communication with customers, aims to minimize the impact on individuals with diabetes relying on the t:slim X2 insulin pump for their healthcare management.
The FDA’s classification of the insulin pump recall as a Class I recall underscores the seriousness of the potential risks posed by the defective iOS app software. Tandem Diabetes Care’s cooperation with regulatory authorities and commitment to customer safety are evident in their proactive measures to address the issue promptly. By notifying customers of the recall and providing a solution through the updated mobile app version, the company aims to prevent further incidents of premature pump shutdown and related health complications among individuals using the t:slim X2 insulin pump.
Despite no reported deaths related to the issues as of April 15th, the FDA and Tandem Diabetes Care are taking the necessary precautions to ensure the safety and well-being of individuals using the t:slim X2 insulin pump. The potential for hyperglycemia and diabetic ketoacidosis resulting from under-delivery of insulin underscores the importance of promptly updating the iOS t:connect mobile app. Tandem’s guidance on monitoring battery levels, particularly during sleep, and their efforts to reach out to affected customers demonstrate their dedication to addressing the issue and protecting the health of individuals with diabetes who rely on their insulin pump for daily management.
In conclusion, the recall of the iOS t:connect mobile app version 2.7 highlights the critical role of software reliability in medical devices such as insulin pumps. Tandem Diabetes Care’s recall and software update process, along with the FDA’s classification of the recall as Class I, underscore the importance of addressing potential safety issues in healthcare technology promptly. By following Tandem’s recommendations and ensuring the app is updated to version 2.7.1 or later, individuals using the t:slim X2 insulin pump can mitigate the risk of premature pump shutdown and associated health complications. Proactive measures by regulatory agencies and medical device manufacturers are essential in ensuring the safety and well-being of patients relying on such devices for their medical needs.