The US Food and Drug Administration (FDA) informed about it Class I recalled For the t:connect mobile app on iOS to control and manage the t:slim X2 insulin pump used by people with diabetes. It was the first smartphone app that could program insulin doses FDA approved. The agency issued the highest possible recall because the app has serious software issues that could lead to life-threatening situations or even death. In fact, although no deaths have been reported, the FDA has received 224 reports of injuries as of April 15.
According to the agency, version 2.7 of the t:connect mobile app contained a bug that started a cycle where the app would crash and then be restarted repeatedly by the iOS platform. This probably caused too much Bluetooth communication, which would drain the pump’s battery and cause it to shut down sooner than the user expected. Insulin pumps like the t:slim X2 are designed to automatically deliver insulin under the user’s skin at set intervals and when needed. They must shoulder the burden of managing the user’s sugar levels so they can go about their day without having to stop and inject themselves or become prone to hypo or hyperglycemia.
If the pump shuts off without warning and before the user waits, this can cause an underdelivery of insulin. As the FDA explained in its recall, this can result in life-threatening hyperglycemia and even diabetic ketoacidosis, caused by the body’s inability to convert sugar into energy due to insulin deficiency. Tandem Diabetes Care, the company behind the app and the pump, sent an emergency alert to all affected customers in March. She advised them to update their software, keep a close eye on pump battery levels and carry spare insulin supplies. The FDA’s recall notice may reach potentially affected customers who may have overlooked or disregarded the manufacturer’s warnings. The insulin pumps were faulty associated with multiple deaths in the past, users may want to take a closer look at themselves, regardless of brand.
