Diabetics In WA & OR Face Serious Recall of Insulin Pump Program

Technology is a wonderful thing, but it isn't full proof.  There have been a number of innovations regarding insulin pump technology over the years to make life easier for people with Type 1 and Type 2 Diabetes that are insulin dependent.

Tandem Diabetes Care was subject to a Class 1 recall for their mobile app that works in conjunction with their t:slim X2 insulin pump.  The issues began back in march when version 2.7 of their mobile app would crash, resulting in depletion of the pump's battery.

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A Class 1 FDA recall is the most serious type of recall that can be issued.  It means there is potential for serious injury or death.  As the issue with version 2.7 of the Mobile app continued, the FDA  stepped in.

The is a very specific recall.  It only impacts Apple.  The recalled t:connect mobile app is an Apple iOS-based software. The t:connect mobile app works with the t:slim X2 insulin pump with Control-IQ technology.  Even though it is very specific it impacts 85,863 devices.

The t:slim X2 insulin pump is intended to deliver insulin under the skin, and set at variable rate to help manage the insulin for someone with diabetes that is insulin dependent.  The issue causes the software to crash, then relaunch with the iOS system.  The repeating of that cycle drains the pump's battery.

That in turn can suspend insulin delivery which may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin.  If you have a Tandem Diabetes Care t:slim and use the app on your iphone you should have already heard from the company. If you haven't click here for more information on how to update your software.