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26th July 2023
Urgent Field Safety Notice
Product: FreeStyle LibreLink app for Android, version 2.10.0
Reference: ADC FA1032-2023
Communication from Manufacturer
Dear Health Care Professional:
We are reaching out to let you know about some important information regarding version 2.10.0 of the FreeStyle LibreLink app for Android in the United Kingdom.
Problem / Issue
Following the release of the FreeStyle LibreLink Android app version 2.10.0 on 12th July, 2023, in the United Kingdom, our internal testing identified an issue. Some FreeStyle Libre 2 customers may experience instances where outdated glucose readings appear as current readings during periods of signal loss. These customers may also not receive signal loss alarms. If you have downloaded Android app version 2.10.0, simply have your patients power their phone off and back on to prevent and permanently resolve the issue.
This does not impact your patients if they:
- Are only using FreeStyle Libre Sensors
- Are using FreeStyle LibreLink Android app version 2.8.4 or earlier
- Are using the FreeStyle LibreLink iOS app
- Are using the FreeStyle LibreLink app (Android or iOS) from another country outside the United Kingdom
We sincerely apologise for any inconvenience this may cause.
Potential Harms
Customers who have upgraded their FreeStyle LibreLink Android app to version 2.10.0 and are using FreeStyle Libre 2 Sensors may be exposed to the following potential harms:
- Outdated glucose readings appearing as current readings. This could lead to undetected low or high glucose, which could result in incorrect or delayed treatment, including not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.
- Missed signal loss alarms. This could lead to undetected low or high glucose, which could result in delayed treatment, including not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.
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