BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25125696 · Received May 8, 2026

    Report

    Report Number
    3019004087-2026-46411
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 8, 2026
    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

    THE USER EXPERIENCED SEVERE HYPOGLYCEMIA RESULTING IN SEIZURE REQUIRING EMS TRANSPORT AND HOSPITALIZATION WHILE ON ILET THERAPY. ENGINEERING LOG REVIEW CONFIRMED THAT DEVICE DATA CORRESPONDING TO THE REPORTED EVENT DATE WERE AVAILABLE AND SHOWED NO MALFUNCTION ALERTS, NO FACTORY RESET, AND NO MOTOR ERRORS; THE ILET WAS DELIVERING INSULIN AS REQUESTED AND RESPONDING APPROPRIATELY TO CGM GLUCOSE VALUES. THE EVENT OCCURRED DURING SLEEP AND LIMITED ADDITIONAL INFORMATION WAS AVAILABLE REGARDING CONTRIBUTING FACTORS. BASED ON AVAILABLE INFORMATION, NO DEVICE MALFUNCTION WAS IDENTIFIED AND THE CAUSE REMAINS NOT ESTABLISHED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2026 IT WAS REPORTED THAT ON (B)(6) 2026 THE USER EXPERIENCED HYPOGLYCEMIA WITH BLOOD GLUCOSE (BG) LEVELS OF 21 MG/DL, RESULTING IN HOSPITALIZATION. EMERGENCY MEDICAL SERVICES WERE CONTACTED, AND THE USER WAS TRANSPORTED TO THE HOSPITAL WHERE THE USER WAS ADMITTED ON (B)(6) 2026, TREATED WITH IV DEXTROSE, AND DISCHARGED ON (B)(6) 2026. NO LONG-TERM HEALTH EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49735 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1