The FDA has issued an urgent Class I recall for version 2.7 of the t:connect iOS app, which interfaces with the t:slim X2 insulin pump, citing significant health risks including potential severe injuries or death.
Understanding Insulin Pumps
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According to the US FDA, at least 224 diabetes patients suffered from injuries linked to a glitch on t:connect iOS which shut down insulin pumps prematurely.
Insulin pumps are critical for managing Type 1 diabetes, a condition where the pancreas produces minimal or no insulin. This deficiency prevents sugar from moving from the bloodstream into cells, leading to potentially dangerous sugar build-ups.
Insulin pumps provide a convenient and reliable alternative to manual insulin injections by automatically administering precise insulin doses based on blood sugar levels, even during sleep.
Critical Issue with t:connect iOS App
The t:connect iOS app, designed to control the t:slim X2 pump, plays a huge role by instructing the pump on when and how much insulin to inject.
However, as the FDA points out, version 2.7 of the app has been experiencing crashes that lead to repeated restarts. Each restart attempts to re-establish Bluetooth connections, significantly draining the battery life of the connected insulin pump.
Risks and Implications of the App Malfunction
The continuous cycle of crashing and restarting not only depletes the pump's battery faster but may also cause the pump to shut down unexpectedly, per 9to5Mac.
The FDA has categorized this as a Class I recall, indicating a reasonable probability that continued use of the app could result in serious adverse health consequences or even death.
To date, there have been 224 reported incidents of injuries related to this malfunction, although no deaths have been reported. Users of the t:connect iOS app are strongly advised to update to the latest version 2.7.1, which contains a fix for the crashing issue.
"Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia," Tandem Diabetes Care warned in its letter to customers two months ago.
Related Article: Insulin Delivery App Gets FDA Clearance for iOS and Android
Here's What Users Should Do
Users should immediately ensure their app is updated to the latest version to prevent further issues. It is also recommended to keep the insulin pump fully charged, particularly before sleeping, and to respond promptly to any low-battery warnings. These precautions are essential to maintain the functionality of the insulin pump and to safeguard against the risks of unmanaged blood sugar levels overnight.
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