insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
iLet Bionic Pancreas, REF: BB1001
Software versions 1.4.3, and 1.4.2
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.