FREESTYLE LIBRE 3 PLUS (ABBOTT DIABETES CARE INC) — Malfunction
A malfunction event was reported regarding the FreeStyle Libre 3 Plus device manufactured by Abbott Diabetes Care Inc. and documented in the FDA database on April 30, 2026.
The manufacturer, Abbott Diabetes Care Inc., and regulatory/quality professionals responsible for the oversight of continuous glucose monitoring systems.
The reporting of a malfunction suggests a deviation from the device's intended performance specifications. While the source does not provide specific technical details or the root cause, such reports are a critical component of the FDA's post-market surveillance. Regulatory teams may need to assess whether this indicates a recurring technical issue requiring CAPA or localized performance variance.
Regulatory and QA teams should review internal malfunction reporting thresholds for continuous glucose monitors. Ensure post-market surveillance workflows are capturing similar performance deviations to maintain compliance with adverse event reporting requirements.
Event type: Malfunction. Device: FREESTYLE LIBRE 3 PLUS by ABBOTT DIABETES CARE INC.
Open in openFDA / FDA.gov