The 2.7 version of the Apple iOS t:connect mobile app, which is used with the t:slim X2 insulin pump with Control-IQ technology, is under a Class 1 recall.
A software glitch in a mobile app used in conjunction with an insulin pump prompted a recall after 224 individuals throughout the United States were injured. No deaths have been reported.
The U.S. Food and Drug Administration (FDA) reported that the 2.7 version of the Apple iOS t:connect mobile app, which is used with the t:slim X2 insulin pump with Control-IQ technology, is under a Class 1 recall, the most serious recall, as the device’s use could result in injury or death.
A glitch drains the insulin pump’s battery sooner than expected. The software glitch crashes the app, forcing the iOS operating system to relaunch. This cycle then repeats, expending excessive energy on Bluetooth communication and depleting the pump battery. Once the pump battery is drained, it shuts down.
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“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 stated in its recall notice.
The insulin pump is produced by Tandem Diabetes Care, Inc. It delivers insulin under the skin at varying rates to help people manage their diabetes. The t:slim X2 insulin pump is one of many subcutaneous insulin pumps on the market.
The mobile app with the software glitch was released on the Apple iOS platform on Feb. 12, 2024. Tandem Diabetes Care released a new version of the app on March 18, and affected customers were notified about the issue on March 26. The recall affected 85,863 devices. The FDA noted that the recall did not remove devices from the market since the problem could be fixed with an application update.
Update to Latest Version of the App
Tandem Diabetes Care urged consumers to monitor the pump battery levels to ensure the pump is nearly or fully charged before going to sleep to help prevent a shutdown. Consumers should also carry backup supplies for insulin delivery in case of a pump failure.Any consumers with the t:slim X2 insulin pump still using the 2.7 version should update the mobile app to the 2.7.1 version, available in the Apple App Store. Technical support is available at TechSupport@TandemDiabetes.com or 877-801-6901. After updating, consumers can continue to use the pump as usual, but the company recommends paying close attention to all system alerts and alarms.
Use of Personal Insulin Pumps on the Rise
According to the U.S. Centers for Disease Control and Prevention (CDC), roughly 38.4 million Americans, or approximately one in 10, have diabetes. Many rely on personal insulin pumps and continuous glucose monitoring systems like the t:slim X2 insulin pump to manage their glucose and diabetes. According to a study in
Clinical Diabetes, the usage of personal insulin pumps jumped from about 50 percent in 2017 to 66 percent in 2021.
While personal insulin pumps have many advantages, they also come with risks tied to reliance on technology. For example, in January 2023, a
data breach compromised user health information for those using insulin pumps manufactured by Insulet. In 2022, an
Insulet pump was recalled after the batteries began to swell, leak fluid, and overheat.
In 2021, Medtronic recalled MiniMed 600 series pumps and 500 series remotes due to a clear retainer ring that could give the wrong insulin dose. This followed a 2018 recall of the MiniMed 508 and Paradigm remote controllers, which unauthorized users could hijack and control.
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