FreeStyle Libre 2 Plus (Abbott Diabetes Care Inc) — Injury
The FDA recorded a report of injury involving the FreeStyle Libre 2 Plus device, manufactured by Abbott Diabetes Care Inc. The source document classifies the event under the category of injury.
This affects Abbott Diabetes Care Inc, regulatory and quality teams managing continuous glucose monitoring (CGM) systems, and post-market surveillance professionals in the diabetes care sector.
The reporting of an injury associated with a high-volume CGM device signifies a potential safety signal that may require monitoring for patterns. For regulatory teams, this necessitates a review of existing risk management files and ensuring that the event has been properly categorized and reported under 21 CFR Part 803. The source provides limited detail on the nature of the injury, suggesting that the immediate impact is focused on routine safety data collection rather than a confirmed systemic failure.
Quality and clinical teams should ensure robust tracking of adverse events related to this specific sensor model and verify that internal reporting timelines for injuries are met. Post-market surveillance data should be reviewed to determine if this injury represents an isolated event or a trend requiring CAPA investigation.
Event type: Injury. Device: FreeStyle Libre 2 Plus by Abbott Diabetes Care Inc.
Open in openFDA / FDA.gov