Insulin pump-related iOS app crash led to accidents
The U.S. Meals and Drug Administration has issued a recall correction for an app that connects with an insulin pump attributable to a software program concern that causes the app to crash, which might drain the battery of the insulin pump and has led to over 200 accidents.
This can be a Class 1 recall, which the FDA says is essentially the most critical kind of recall, and use of the machine can result in critical damage or demise.
The recall is for Model 2.7 of the t:join cellular app, and Apple iOS-based software program that works with the t:slim X2 insulin pump with Management-IQ know-how. The app will also be used as a way of viewing pump data and restricted management of the pump by means of appropriate smartphone fashions, working methods and pump software program variations.
The recalled model of the app was distributed between Feb. 12 and March 13, 2024. The FDA has recalled 85,863 units within the U.S.
In line with the FDA, there is a matter with the app’s software program that may trigger it to crash and be mechanically relaunched by iOS. This cycle can repeat, which results in “extreme” Bluetooth communication that can lead to a pump battery drain and might result in the pump “shutting down ahead of sometimes anticipated.”
When the pump is shut down, insulin supply is suspended, which might result in an under-delivery of insulin and should lead to hyperglycemia and even diabetic ketoacidosis, a life-threatening situation.
The FDA mentioned there have been 224 accidents as of April 15. No deaths have been reported.
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What to do concerning the recall
Tandem Diabetes Care despatched all affected prospects an Pressing Medical System Correction on March 26, which requested prospects to replace the cellular app to model 2.7.1 or later within the Apple App Retailer.
Prospects have been additionally requested to finish an internet type acknowledging receipt of the discover, and to proceed to make use of the pump as described within the Person Information, being attentive to all system alerts and alarms.
They have been additionally requested to watch the pump battery stage carefully to make sure the pump is at or close to full cost earlier than going to sleep to assist forestall pump shutdown, and to start charging the machine after the primary low battery alert.
Customers have been advised to at all times carry backup provides for insulin supply in case of pump failure.
The right way to contact Tandem Diabetes Care
Prospects within the U.S. with questions can contact Tandem Diabetes Care Technical Assist Group at 877-801-6901.
