ILET BIONIC PANCREAS (BETA BIONICS, INC.) — Malfunction
FDA received a report regarding a device malfunction involving the iLet Bionic Pancreas manufactured by Beta Bionics, Inc.
This affects Beta Bionics, Inc., as well as regulatory and quality assurance departments monitoring safety performance of automated insulin delivery (AID) systems.
A reported malfunction in a bionic pancreas system suggests potential risks to glucose management protocols. From a regulatory perspective, this necessitates close monitoring of the manufacturer's Corrective and Preventive Action (CAPA) processes and may indicate a need for further investigation into the failure mode to ensure patient safety and device reliability.
Quality systems teams should ensure that post-market surveillance activities for automated insulin delivery systems are captured in adverse event reporting workflows. Regulatory personnel should monitor further FDA communications for potential recall designations or corrective action requirements.
Event type: Malfunction. Device: ILET BIONIC PANCREAS by BETA BIONICS, INC..
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