| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00847-1 |
| Product Name/Description |
Mylife App Software
Affected app installations: The identified defect affects all app versions from v2.1.1 upwards
Android:
v2.4 (UDI 111652811196V2.4)
v2.4 (UDI 111652811196V2.3)
v2.4 (UDI 111652811196V2.2)
v2.4 (UDI 111652811196V2.1.1)
iOS:
v2.4 (UDI 111784431122V2.4)
v2.3 (UDI 111784431122V2.3)
v2.2 (UDI 111784431122V2.2)
v2.1.1 (UDI 111784431122V2.1.1)
ARTG 428030
(Ypsomed Australia Pty Ltd - Diabetes patient management software) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
When a bolus is being delivered and, concurrently, the App is automatically synchronising with the mylife Cloud, the bolus might not be saved in the mylife App. In the synchronisation between both processes, there is a short time windows, where saving and synchronising may overlap and remove the bolus from logbook. While visible in the YpsoPump logbook, the bolus is subsequently notconsidered for the insulin on board. The missing bolus in the mylife App logbook causes an incorrect insulin on board calculation that may lead to incorrect dosing of subsequent boluses.
The identified defect impacts all users of the mylife App that are using an YpsoPump synchronising their data with the mylife Cloud and using the Bolus Calculator to calculate (and deliver) bolus insulin.
Users in Pen mode (MDI therapy) are not affected by this problem. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
All users are recommended to disable the automatic Cloud synchronisation as an interim measure. To disable the automatic synchronisation with the mylife Cloud:
1. Go to Settings – Personal data
2. Sign out
3. Sign in
4. Switch off the Keep me logged in option
If data in the mylife Cloud is required, please synchronise data manually.
The update of the corrected mylife App is targeted for release in the Google PlayStore and in the Apple App Store in the second half of October 2024. Once the new app release is available, users will receive a notification in the app to update their current installation. |
| Contact Information |
1800 447 042 - Ypsomed |