ILET BIONIC PANCREAS (BETA BIONICS INC.) — Injury
A user of the iLet Bionic Pancreas reported concern regarding potential hypoglycemia while the system indicated eight units of insulin on board during a period of elevated blood glucose. Although insulin delivery was manually paused by the user due to anxiety, an investigation confirmed no device malfunction or missed alarms occurred.
Beta Bionics Inc., manufacturers of automated insulin delivery systems, and clinical educators responsible for user training on algorithmic dosing.
This report highlights the intersection of automated device logic and user perception of risk. While no mechanical or software malfunction was found, the incident resulted in an intervention (user-initiated pause) and a requirement for additional training. This suggests that for complex bionic systems, regulatory teams must ensure user education effectively manages expectations regarding automated insulin stacking and trending data to avoid unnecessary clinical anxiety.
Regulatory and QA teams should evaluate if current user training materials sufficiently address insulin-on-board logic to prevent user anxiety or unauthorized dosing pauses. Post-market surveillance should continue to monitor for trends where user intervention overrides automated system logic in the absence of a device malfunction.
Event type: Injury. Device: ILET BIONIC PANCREAS by BETA BIONICS INC.. IT WAS REPORTED THAT A USER OF THE ILET REPORTED CONCERN ABOUT IMPENDING HYPOGLYCEMIA DUE TO HAVING 8 UNITS OF INSULIN ON BOARD WHILE BLOOD GLUCOSE WAS ELEVATED AROUND 292 MG/DL AND TRENDING DOWN, AND THE USER PAUSED INSULIN DELIVERY AND REQUESTED TO SPEAK WITH A CLINICIAN. SYMPTOMS INCLUDED ANXIETY ABOUT LOW BLOOD GLUCOSE. OUTCOMES INCLUDED NO REPORTED INJURY, HOSPITALIZATION, OR ALARMS. INVESTIGATION INCLUDED TROUBLESHOOTING AND USER EDUCATION WITH ASSIGNMENT FOR ADDITIONAL TRAINING. INVESTIGATION OF THIS CASE REVEALED NO DEVICE ALARMS AND NO CONFIRMED DEVICE MALFUNCTION. IT WAS CONCLUDED, B
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