United States: An iOS software connected to a particular type of insulin pump used by diabetics has been the subject recently, the most serious sort issued by the U.S. Food and Drug Administration.
Functional Issue
The Apple iOS t:connect mobile app, version 2.7, is the subject of the recall notice, which the FDA describes as a “correction” as opposed to a product removal. It works in tandem with the Control-IQ equipped t:slim X2 insulin pump.
The program may frequently crash and then restart, which is the issue. This gradually depletes the insulin pump’s battery, which is necessary for patients to remain healthy. Because of this problem, around 86,000 of the applications have already been recalled.
Risk Assessment
” Pump arrestment will beget insulin delivery to suspend, which could lead to an under- delivery of insulin and may affect in hyperglycemia or indeed diabetic ketoacidosis, which can be a life- hanging condition due to high blood sugars and lack of insulin,” the Food and Drug Administration said in a statement issued Thursday.
Injury Concerns
As of April 15, the association is apprehensive of 224 injuries that have been recorded due to this problem. There have been no recorded fatalities.
Users of the Apple iOS platform’s t:slim X2 Insulin Pump Mobile App version 2.7 may be impacted.
Tandem Diabetes Care, Inc. has recalled version 2.7 of the t:connect mobile app, which was initially made available on the Apple iOS platform on February 12, 2024, according to the FDA notification. It functions in tandem with the t:slim X2 insulin pump, which subcutaneously administers insulin at different but precise rates.
Manufacturer Response
Users are advised to update to version 2.7.1 or higher of the software by Tandem. The Apple App Store has it accessible.
Following that:
To find the t:connect mobile app’s software version, launch it, click the “Setting” button on an iPhone, and then select “About.”
To confirm receipt of this notification, fill out the External Link Disclaimer online form.
Continue operating the pump in accordance with the User Guide’s instructions, being mindful of any system alerts or alarms.
Before going to bed, make sure the pump is fully charged, or almost fully charged, to assist avoid pump shutdown.
After the initial low battery message, start charging the smartphone.
Always have extra insulin delivery supplies on hand in case your insulin pump breaks down.