| TGA Action ID |
RC-2025-RN-00628-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Dexcom G7 App & Dexcom One + App
Versions: V2.8.0 and earlier (iOS and Android), Version 1.4.0 and earlier (iOS and Android)
Product Codes: SW12299 G7 App, SW12300 G7 App, SW13355 G7 App, SW14245 D1G7, SW14244 D1G7 |
| ARTG Number |
169241 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
Dexcom recently identified a bug within the Dexcom G7 and Dexcome One+ apps that can cause a problem where, when a transmitter error occurs, the app terminates the sensor session and prompts the user to “start a new sensor”, without providing a “sensor failed” alert.
If a user is unaware that the sensor session has terminated, there is the potential for missed detection of a hyperglycaemic or hypoglycaemic event. |
| Instructions for Customers/Users |
Dexcom G7 and One+ users are to open the App Store on their device, and search for the relevant Dexcom G7 or One+ app. Users should then install the latest version of the app to rectify this problem.
Upgrading from the G7 app (Version 2.8 or earlier) and One+ (Version 1.4 or earlier) is mandatory, and must be done by 20 August 2025. Users will not be able to use older versions of the app after this date.
This action has been finalised on 4/11/2025. |
| Action Commencement Date |
16/07/2025 |
| Responsible Entity |
|
| Contact Information |
1300 851 056 - Dexcom Technical Support |