An iOS app designed to help manage diabetes has caused harm to over 220 people due to a defect in the application.
Tandem Diabetes Care, a diabetic management organization, is recalling the app used with the t:slim insulin pump due to a software issue.
According to the US Food and Drug Administration (FDA), the mobile app allegedly crashes frequently and automatically relaunches, creating a cycle that leads to “excessive Bluetooth communication,” which drains the pump’s battery and could cause it to shut down sooner than anticipated.
“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 FDA said.
There have been reports of 224 injuries as of April 15th, 2024, and no deaths related to the incident.
The FDA recalled version 2.7 of the t:connect mobile app, which is Apple iOS-based software used with the t:slim X2 insulin pump with Control-IQ technology.
The mobile app can be used to check pump information and the t:slim X2 insulin pump is designed to deliver insulin under the skin to help manage diabetes.
Users with the application have been directed to update the mobile app to version 2.7.1 or later, which is available on the app store. Individuals should complete an online form and monitor the battery level closely to avoid pump shutdown.
The FDA recommends that users “continue to use the pump as described in the user guide and pay attention to all systems alerts and alarms.”
