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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 Customer:

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 Some FreeStyle Libre 2 customers may experience instanceswhere outdated glucose readings appear as current readings during periods of signal loss.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 power your phone off and back on to prevent and permanently resolve the issue.

This does not impact you if you:

  • 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  • Outdated glucose readings appearing as current readings.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.

Actions for You

If you have upgraded to FreeStyle LibreLink Android version 2.10.0, simply power your phone off and back on to prevent and permanently resolve the issue.

If you have not already upgraded your FreeStyle LibreLink Android app to version 2.10.0, we advise delaying upgrading until receiving further communication from Abbott.

Find your App Version

To check which app version you are using, follow the instructions below:

  • Open your FreeStyle LibreLink app
  • Tap ‘Menu’ then tap ’About’
  • The app version will be listed on this screen under Software Full Version

We have notified the Medicines and Healthcare products Regulatory Agency (MHRA) and we are working to correct this issue. We will notify you when an updated app version is available.

If you have any further questions or would like to report an issue, please call FreeStyle customer service at 0800 170 1177. The team is available 08.00 – 20.00 (Monday – Friday) excluding Bank Holidays, and 09.00 – 17.00 Saturday.

Sincerely,

Abbott, Diabetes Care

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