Advice
Regulatory information
Regulatory information
The Dexcom G6 continuous glucose monitoring system (including the applicator and the app) is a CE-marked class IIb medical device.
The following manufacturer field safety notices or medical device alerts for this technology (Dexcom G5 or G6) have been identified.
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Users of the Dexcom G6 iOS App with versions before 1.54 were alerted that they may not receive their scheduled alerts. Dexcom advised users to update their apps. If the app was not updated, it was blocked from use (on 9 December 2019). Medicine and Healthcare products Regulatory Agency field safety notice (December 2019).
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The notice advised users of Dexcom G5 that the alert about sensor glucose readings not being received did not have an audible prompt. The company advised users to periodically check the app for the status of their sensor glucose readings. Medicines and Healthcare products Regulatory Agency field safety notice (June 2019).