Urgent Product Defect Correction - Guardian Connect iOS Update – Medtronic
5 June 2019
Medtronic are making people aware of a potential issue with the transmitter battery life of the Guardian™ Connect Continuous Glucose Monitoring (CGM) system. Customers using an Apple device with iOS version 12 or higher are being advised to update to the latest version (3.2.4) of the Guardian™ Connect app on their iPhone as soon as possible. Medtronic are providing this information to all patients who have received the Guardian™ Connect CGM system and are using it with iOS. Medtronic is issuing this notice in consultation with the Therapeutic Goods Administration.
Explanation of the Issue: Medtronic recently became aware that customers using the Guardian™ Connect app on an iPhone, iPad or iPod Touch with iOS software version 12, 12.1, or 12.2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge. The iOS12 update created more frequent Bluetooth® connections that drain the transmitter battery faster than under the previous iOS versions. Rest assured, this does not impact sensor performance and the CGM system will work as expected, aside from having a shorter transmitter battery life. The system will continue to provide correct information about battery life and alerts related to low battery (as displayed below). While Medtronic have received reports from customers about the shorter battery duration of the transmitter Medtronic have not received any reports of injury.
- Patients using iOS version 12 or higher should update their Guardian™ Connect app now to the latest version (v3.2.4) located on the App Store®. This update will return the Guardian™ Connect transmitter to the same battery performance experienced before the iOS 12, 12.1, and 12.2 updates.
- Medtronic recommend patients not using iOS 12 or higher to still update to the latest version of the Guardian™ Connect app.
Medtronic are committed to patient safety and appreciate your prompt attention to this matter. If you continue to experience issues or have questions, please contact their Global Help Line on 1800-777-808.