BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23490612 · Received November 6, 2025

    Report

    Report Number
    3019004087-2025-06987
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    September 17, 2023
    Report Date
    November 6, 2025
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BETA BIONICS, INC. RECEIVED VOLUNTARY MEDWATCH REPORT MW5168715 FORWARDED BY THE FDA ON 08-APR-2025. THE REPORT ALLEGED THAT A USER EXPERIENCED MULTIPLE EPISODES OF SEVERE HYPOGLYCEMIA ATTRIBUTED TO EXCESSIVE INSULIN DELIVERY BY THE ILET BIONIC PANCREAS SYSTEM.THE VOLUNTARY REPORT DID NOT CONTAIN PATIENT IDENTIFIERS, SERIAL NUMBER, OR CONTACT INFORMATION. THE REPORTER PROVIDED THE FCC ID INSTEAD OF THE SERIAL NUMBER, PREVENTING DEVICE TRACEABILITY. BETA BIONICS WAS THEREFORE UNABLE TO IDENTIFY OR EVALUATE THE SPECIFIC DEVICE.THE MEDWATCH REPORT INDICATED THE PATIENT WAS A 4-YEAR-OLD FEMALE, WHICH IS BELOW THE INDICATED AGE RANGE FOR THE ILET SYSTEM. PER THE ILET BIONIC PANCREAS SYSTEM USER GUIDE (LA000081, SECTION 1.2 AND 1.6), THE DEVICE IS INDICATED FOR INDIVIDUALS 6 YEARS OF AGE OR OLDER WITH TYPE 1 DIABETES MELLITUS AND USE IN INDIVIDUALS UNDER 6 YEARS OF AGE CONSTITUTES OFF-LABEL USE.NO PRODUCT RETURN, LOG DATA, OR CORROBORATING INFORMATION WAS AVAILABLE TO CONFIRM THE EVENT. BASED ON THE AVAILABLE INFORMATION, BETA BIONICS COULD NOT DETERMINE A ROOT CAUSE OR CONFIRM A DEVICE MALFUNCTION. THIS MDR IS BEING SUBMITTED SOLELY BASED ON THE VOLUNTARY REPORT RECEIVED. BETA BIONICS WILL FILE A FOLLOW-UP MDR IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    A VOLUNTARY MEDWATCH REPORT WAS RECEIVED VIA THE FDA ON 08-APR-2025 ALLEGING THAT A USER EXPERIENCED MULTIPLE SEVERE HYPOGLYCEMIC EPISODES DESCRIBED AS ¿MAJOR INSULIN OVERDOSES¿ WHILE USING THE ILET BIONIC PANCREAS SYSTEM. THE REPORTER STATED THAT THE PUMP DELIVERED EXCESSIVE INSULIN, LEADING TO NEAR-FATAL EVENTS REQUIRING THE ADMINISTRATION OF ORAL CARBOHYDRATES, ONDANSETRON, AND GLUCAGON (BAQSIMI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893599 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Required Intervention| L DEXCOM CONTINUOUS GLUCOSE MONITOR