A glitch in an iOS app that controls the insulin pumps for people with diabetes has injured over 200 people, the US Food and Drug Administration said on Wednesday, in an eerie example of smart tech going awry.
In a press release, the FDA said that it's issued a recall for version 2.7 of the app, t:connect, which pairs with the t:slim X2 insulin pump manufactured by Tandem Diabetes Care. The faulty software was causing the app to continuously crash and relaunch on Apple smartphones in a never ending loop, sending excessive Bluetooth signals to the pump that drained its battery at a rapid rate.
The order only involves the software update and doesn't mean that the devices will have to be returned. But the graveness of the issue should not be understated; the FDA has designated the order as a Class 1 recall — its most serious type — because using the pumps could cause serious injury or death. Nearly 86,000 devices are affected.
"Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin," the agency said in the release.
Diabetes, a chronic disease in which the body is unable to produce enough insulin to manage blood sugar levels, can require lifelong treatment and monitoring. In the US, over 38 million people have some form of the disease, according to the US Centers For Disease Control and Prevention, while about 350,000 people in the US use an insulin pump to treat diabetes.
Insulin pumps regularly deliver the essential hormone into the body, which would otherwise need to be injected by hand. Most patients need around three injections per day. Missing these doses of insulin can cause severe and even life-threatening symptoms. It's absolutely crucial, then, that these pumps work around the clock without incident.
Tamdem's t:slim X2 pump failed horribly on that front. So far, 224 injuries have been reported, the FDA said. According to a letter Tandem sent to customers in March, there were 81 "adverse events," with one injury requiring medical intervention. There are no reported deaths.
The company notes that its pumps send out a low power alert and an alarm prior to a shutdown — but of course, by the time these go out it may already be too late, should a user not have a charger on hand. If a shutdown occurs while someone's asleep, it could be fatal.
What is arguably most alarming is that the faulty version 2.7 was released all the way back in February. The app was not updated to address the issue until late March, and the public recall was not issued until May. That's a terribly long window to keep your customers in harm's way, and it's perhaps only by extremely good fortune that more people weren't hurt.
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