| TGA Action ID |
RC-2025-RN-00568-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Dexcom G6 OUS iOS App (SW11585: mg/dL app and SW11586: mmol app) |
| ARTG Number |
169241 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
In September 2023, the V1.11.0 G6 OUS iOS apps (SW11585: mg/dL app and SW11586: mmol app) were released. After receiving customer complaints, it was discovered that users of v1.11.0 G6 OUS iOS may expect stale Estimated Glucose Value (EGV) readings in Mag glass and Trend Graph on the Home screen.
In this situation, the view of the trend graph in the Home screen is not synchronised with the other views from Widget, Watch app, or Follow app.
This market action was undertaken prior to TGA notification. |
| Instructions for Customers/Users |
Customers are to note that:
· G6 OUS iOS Version 1.11.2 containing the software fix was released on 07 December 2023.
· The product obsolescence process for the Dexcom G6 iOS CGM App version 1.11.0 has been completed in Australia.
· Dexcom confirmed on 22 May 2025 that there are no active users of the G6 iOS CGM App version 1.11.0 remaining in Australia.
As a result, the problem has been effectively resolved through the release of the updated version.
This action has been closed out on 09/07/2025 |
| Action Commencement Date |
7/07/2025 |
| Responsible Entity |
|
| Contact Information |
1300 851 056 - Dexcom Technical Support |