FDA Recall Effects North Dakotan Diabetics
The US Food and Drug Administration (FDA) reports that at least 224 diabetics have reported injuries associated with malfunctioning iOS software that resulted in their insulin pumps shutting down too soon.
The government declared on Wednesday that Tandem Diabetes Care, a California-based producer of medical devices, had recalled version 2.7 of the iOS t:connect software, which is compatible with the company's t:slim X2 insulin pump.
The recall is specifically related to a software bug that may result in the app crashing and relaunching frequently, eventually draining the pump's battery through excessive Bluetooth connection.
Tandem states that although the pump will advise customers of an impending shutdown with an alarm and low-power alert, this battery drain may lead the pump to shut down "earlier than typically expected." Customers are advised to update the mobile app to version 2.7.1 or higher by the corporation, as this should resolve the problematic software.
With appropriate smartphone models, operating systems, and pump software versions, users can also examine pump information and have limited control over the pump by using the t:connect mobile app.
The t:slim X2 insulin pump is designed to provide insulin subcutaneously (under the skin) at fixed or variable rates to individuals who need it for the treatment of diabetes. It can safely establish connections with other gadgets, such as insulin dosage software. In conjunction with appropriate continuous glucose monitors and pumps, Control-IQ technology modifies insulin delivery in response to both current and anticipated glucose readings. It also has the capacity to provide additional insulin as required.
Reason for Recall
Due to a correction, Tandem Diabetes Care, Inc. is recalling version 2.7 of the t:connect mobile software, which was launched on February 12, 2024, for the Apple iOS platform. This app is used in connection with the t:slim X2 insulin pump with Control-IQ technology. The recall is the result of a software bug, and the iOS operating system may reload the mobile app right away if it crashes. The intermittent repetition of this cycle results in excessive Bluetooth communication, which might drain the pump's battery and cause the pump to switch down earlier than usual.
Pump failure will stop the delivery of insulin, which could result in hyperglycemia or even diabetic ketoacidosis, a condition that can be fatal due to high blood sugar and inadequate insulin.
As of April 15, 2024, there had been 224 documented injuries and no deaths.
Who Might Be Affected
Individuals with diabetes who could make use of the t:slim X2 Insulin Pump Mobile App (version 2.7) for iOS devices.
Health professionals that might administer care through the Apple iOS platform's t:slim X2 Insulin Pump Mobile App, version 2.7.
Ways to Proceed
An urgent medical device correction was delivered to all impacted customers by Tandem Diabetes Care, Inc. on March 26, 2024.
Customers in the United States should call the Tandem Diabetes Care Technical Support Team at (877) 801-6901 if they have any questions concerning this recall.
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