how automated healthcare fails, how you'd know, and what to do at each tier — every claim sourced, reviewed continuously
Some Libre 3 and 3 Plus continuous glucose sensors read lower than actual glucose; FDA classified the correction Class I after reports of 860 serious injuries and 7 deaths.
TierThe automation stayed up and kept producing output that was wrong or went unchecked; there was no outage to fall back from. How tiers are assigned.
Abbott initiated a correction on 24 November 2025 after finding certain FreeStyle Libre 3 and 3 Plus sensors could give glucose readings lower than actual levels, which could lead users to take excess carbohydrate or skip or delay insulin. FDA classified it Class I. As of 7 January 2026, 860 serious injuries and 7 deaths had been reported. Users were told to check serial numbers, stop using affected sensors and use a blood glucose meter for treatment decisions until replacements arrived.[1,2]
860 serious injuries and 7 deaths reported as of 7 Jan 2026 (FDA).
Information only, not advice. FailSystems is an aggregation and synthesis of published sources. It is not consulting, engineering, legal, regulatory or medical advice, and using it creates no professional relationship. Health systems are complex and no approach fits every organisation: anything you adopt is your own decision, at your own risk, and should be checked against the current official sources and by qualified people who know your setting. Full disclaimer.