Overview: Tandem Diabetes Care, Inc. has issued a recall for Version 2.7 of the Apple iOS t:connect mobile app, used with the t:slim X2 insulin pump featuring Control-IQ technology. This recall, classified as a Class I by the FDA—the most serious type—addresses a software problem causing significant battery depletion in the insulin pumps, potentially leading to pump shutdown and serious health risks.
Details of the Recall:
- Product Name: Version 2.7 of the Apple iOS t:connect mobile app
- Product Code: QFG
- Distribution Dates: February 12, 2024 to March 13, 2024
- Devices Recalled in the U.S.: 85,863
- Initiation Date: March 18, 2024
Device Functionality: The t:connect mobile app enables users to view and control the t:slim X2 insulin pump through compatible iOS devices. The t:slim X2 insulin pump delivers insulin under the skin, using Control-IQ technology to adjust insulin delivery based on glucose readings.
Reason for Recall: A software glitch in the mobile app causes it to crash and relaunch repeatedly, leading to excessive Bluetooth activity that drains the pump’s battery. This can cause the pump to shut down, suspending insulin delivery and risking serious conditions like hyperglycemia or diabetic ketoacidosis.
Reported Incidents: As of April 15, 2024, there have been 224 reported injuries linked to this issue, though no deaths have been reported.
Who is Affected:
- Users of the t:slim X2 insulin pump with the affected mobile app version
- Healthcare providers managing patients with the affected system
Action Steps for Users:
- Update the app to version 2.7.1 or later via the Apple App Store.
- Verify the app version by navigating to ‘Settings’ and then ‘About’ in the app.
- Acknowledge receipt of the notice through an online form.
- Follow pump usage guidelines and monitor system alerts.
- Ensure the pump battery is fully charged, especially before sleep.
- Begin charging the pump after the first low battery alert.
- Carry backup insulin delivery supplies.
For more detailed guidance, affected users should refer to the Urgent Medical Device Correction sent by Tandem Diabetes Care, Inc.