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TGA Action ID RC-2025-RN-00491-1
Type of Product Medical Device
Product Name/Description Dexcom One + iOS App

Version 1.2
ARTG Number 169241
Action Type Product Correction
Action Level Consumer
Hazard Classification Class II
Reason for the Action A bug in the 1.2. version of the Dexcom One+ iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) in the mag glass and continues to show this stale EGV.

The Trend graph may continue to progress in time with no new EGVs added to the graph, or all plotted points may disappear from the graph, or the Trend graph may disappear completely when the app is in this state.

If a user is unaware that glucose values provided by the app are not updating and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycaemic or hypoglycaemic event, or a treatment decision made based on incorrect data.

Through April 2025, there have been no complaints or serious injuries confirmed to be associated with this problem.
Instructions for Customers/Users Customers are to update the app to the latest version which is available on the App Store. Instructions on how to download the update are provided in the customer letter.

The affected version (1.2) of the app will be blocked and cannot be used from 12 June 2025.

This action has been finalised on 1/07/2025.
Action Commencement Date 28/05/2025
Responsible Entity AA-Med Pty Ltd
Contact Information 1300 851 056 - Dexcom Technical Support