BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24821714 · Received April 8, 2026

    Report

    Report Number
    3019004087-2026-41758
    Event Type
    Death
    Date Received
    April 8, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 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 CARDIAC ARREST AND DEATH WHILE USING THE ILET. THIS SITUATION CAN RESULT IN LIFE-THREATENING METABOLIC DECOMPENSATION REQUIRING IMMEDIATE INTERVENTION AND IS CONSISTENT WITH THE REPORTED EMS RESPONSE AND FATAL OUTCOME. ENGINEERING LOG REVIEW INDICATED THE ILET WAS FUNCTIONING AS INTENDED, WITH INSULIN DELIVERY REQUESTS AND ALERTS GENERATED APPROPRIATELY AND NO DEVICE MALFUNCTION IDENTIFIED. DEVICE DATA SHOWED REPEATED LOW GLUCOSE ALERTS IN THE DAYS PRIOR TO THE EVENT AND NO EVIDENCE OF ABNORMAL OR EXCESSIVE INSULIN DELIVERY BEYOND PROGRAMMED REQUESTS. THE USER¿S CAREGIVER REPORTED CHALLENGES WITH ADHERENCE TO THERAPY, INCLUDING MISSED MEAL ANNOUNCEMENTS, FAILURE TO RESPOND TO ALERTS, AND INCOMPLETE SUPPLY MANAGEMENT. BASED ON AVAILABLE INFORMATION, THE EVENT WAS ATTRIBUTED TO USE-RELATED THERAPY MANAGEMENT FACTORS, AND NO DEVICE MALFUNCTION WAS IDENTIFIED. 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 A HYPOGLYCEMIC EVENT WITH BLOOD GLUCOSE REPORTED AS LOW AS 30 MG/DL, RESULTING IN CARDIAC ARREST AND DEATH. THE USER WAS TRANSPORTED BY EMERGENCY MEDICAL SERVICES AND RECEIVED EMERGENCY TREATMENT. THE OUTCOME WAS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878351 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Death DEXCOM G7 CGM