Medical device manufacturer, Dexcom, has issued a medical device safety alert concerning its G6 iOS App [Versions prior to 1.5.4].
The manufacturer identified a state that users of the Dexcom G6 iOS App with versions prior to 1.5.4 may not receive their scheduled alerts. In the worst-case scenario, the affected users may not receive alarms/alerts when their glucose levels are low or high.
According to the manufacturer, the current database code for the Dexcom app deletes values for alerts that are over 30 days ("30-Day Pruning"). If a user has not modified an Alert Setting for 30 days, the old setting will be deleted when the user enables the Alert Schedules feature and the "30-Day Pruning" occurs, resulting in the alert being disabled. Without alarms/alerts, the affected user might miss a severe low or high glucose event. Approximately 1.3% of the users may be impacted.
In order to continue use of the device, all affected users are required to update their Dexcom G6 iOS App with the new version [i.e. 1.5.4] from the Apple App Store. Failure of updating the App may cause their alarms and alerts not work as intended.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 28 November 2019