PharmacovigilanceOfficial

Abbott Libre app security update linked to persistent sensor signal loss, IGJ notice says

🇳🇱 IGJ · Wed 21 Oct 2026

The Dutch inspectorate has published Abbott's field safety notice on the FreeStyle Libre 3 and Libre apps, with a corrective app update still being prepared.

Abbott released a security update for the FreeStyle Libre 3 app and the Libre app on 15 October. According to a field safety notice published by the Dutch health inspectorate IGJ, the update has since been found to cause persistent signal loss for some users.

The notice describes this as the sensor losing its connection to the app and not re-establishing it. The source does not say how many users are affected, which app platforms or versions are involved, or whether any harm has been reported.

Abbott is working to release a new app update that fixes the problem as soon as possible. The company says it will inform users once new updates are available. No interim measures for users are set out in the text published by IGJ.

The notice is dated 18 October 2026 and lists Abbott Diabetes Care Ltd as manufacturer and Abbott BV as authorised representative. A field safety notice is the route by which manufacturers tell users and authorities about post-market actions where a risk to users has been identified.

What it means for your team

  • Teams handling Abbott's CGM products should check whether their market has received the same field safety notice and whether any local user communication is needed.
  • The corrective app update is not yet available, so vigilance and complaint-handling teams should watch for further updates from Abbott and the competent authorities.
  • The case shows that a security-driven software change to a medical device app can itself create a performance and safety issue, which is relevant for software change control and post-market surveillance.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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