| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00882-1 |
| Product Name/Description |
Guardian Connect Mobile App
Part Number: CSS7200
ARTG Number : 276924
(Medtronic Australasia Pty Ltd - Information system software, application program, patient record) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/07/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified an issue in Apple iOS 11.3 & 11.4 that can sometimes prevent patients from receiving a 'Lost Communication' alert after their Guardian Connect app is closed by the iPhone's operating system (iOS) in certain situations. The operating system may close the Guardian Connect App without alerting patients that the app is no longer running or communicating with the Guardian Connect transmitter. If the app is closed, patients will not receive alerts that could be associated with hypoglycaemic or hyperglycaemic events.
Medtronic have received reports from patients regarding the app closing without warning, however, to date, no reports of injury as a result of this issue have been received. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Medtronic is advising users to immediately update their Guardian Connect App to the latest release (v3.2.2) located on the App Store.
Medtronic also reminds users that as described in the App User Guide, Medtronic cannot guarantee that iPhones will always allow for the Guardian Connect App to run in the background. If the iPhone automatically closes your Guardian Connect App, users may receive a ‘Lost Communication’ alert. To ensure users continue receiving sensor glucose data and alerts, Medtronic recommends periodically checking that the Guardian Connect App is still running, being especially mindful of this anomaly when running several applications at once or after using gaming and video Apps which use a lot of the iPhone’s power or memory resources.
This action has been closed out on 11/02/2019 |
| Contact Information |
1800 777 808 - Medtronic Diabetes Helpline |