iLet Bionic Pancreas Insulin Only (REF BB1002)Recalls & reported problems
Beta Bionics, Inc. · iLet Bionic Pancreas (Commercial Starter Kit) · Class 2
All models of iLet Bionic Pancreas (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850050080046), received between Apr 8, 2025 and Apr 8, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Inaccurate Delivery” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Inaccurate Delivery1
Patient problems
- Hypoglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2025Inaccurate Delivery
SOON AFTER COMPLETING ALL REQUIRED TRAINING ONLINE AND WITH THE CERTIFIED PUMP TRAINER EMPLOYED AND ASSIGNED TO ME BY BETA BIONICS, INC., I STARTED USING THIS NEW ILET INSULIN PUMP, I EXPERIENCED A SERIES OF MAJOR INSULIN OVERDOSES WHICH WERE DELIVERED BY PUMP USING LIFE-THREATENING DANGEROUS AND FAULTY ALGORITHMS. AS AN EXPERIENCED INSULIN PUMP USER, I KNEW THESE EVENTS WERE NOT NORMAL, AND ACTUALLY NEARLY KILLED ME BY ADMINISTERING AT LEAST TWO, IF NOT MORE, NEAR FATAL OVERDOSES OF INSULIN, FOR WHICH I HAD NO CONTROL OVER, UNTIL APPROXIMATELY 8-10 HOURS LATER WHEN I JUST HAD TO REMOVE THE DEVICE FROM MY BODY ALTOGETHER. DURING THESE SUDDEN-ONSET OVERDOSES, I NEEDED TO HAVE ASSISTANCE KEEPINGME IN A SEMI-CONSCIOUS STATE SO I COULD CONSUME MASSIVE AMOUNTS OF GLUCOSE TABLETS, SEVERAL DOSES OF ODANSETRON (AN ANTI-EMETIC), HIGHLY CONCENTRATED FRUIT JUICE, AND TWO DOSES OF GLUCAGON (BAQSIMI). I SURELY WOULD HAVE DIED THAT DAY WITHOUT MY FAMILY MEMBER'S RAPID RESPONSE AND ASSISTANCE. EVEN AFTER BLOOD GLUCOSE WOULD BRIEFLY STABILIZE, I SUBSEQUENTLY RECEIVED MORE INSULIN BOLUS OVERDOSES. I FOLLOWED THE TRAINING BY BETA BIONICS EXACTLY AND PRECISELY TO THE LETTER AND STILL NEARLY DIED. THI
Patient problems: Hypoglycemia
MAUDE report 21798235 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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