BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24564851 · Received March 10, 2026

    Report

    Report Number
    3019004087-2026-36885
    Event Type
    Death
    Date Received
    March 10, 2026
    Date of Event
    February 5, 2026
    Report Date
    March 10, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080183
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER EXPERIENCED CARDIAC ARREST RESULTING IN DEATH WHILE REPORTEDLY USING THE ILET. THIS SITUATION CAN RESULT IN SUDDEN CARDIAC COLLAPSE REQUIRING EMERGENCY INTERVENTION AND IS CONSISTENT WITH THE REPORTED CARDIAC ARREST AND EMS RESPONSE. ENGINEERING LOG REVIEW INDICATED THE ILET WAS FUNCTIONING AS INTENDED, WITH NO MALFUNCTION ALERTS OR FACTORY RESETS IDENTIFIED IN THE AVAILABLE LOGS. DEVICE DATA PRIOR TO THE EVENT SHOWED PROLONGED HYPERGLYCEMIA, REPEATED OCCLUSION ALERTS, AND PERIODS WITHOUT INSULIN DELIVERY DUE TO CARTRIDGE DEPLETION AND INCOMPLETE CARTRIDGE LOAD PROCESSES, AS WELL AS CGM SENSOR FAILURE PRIOR TO THE REPORTED DATE OF DEATH. AVAILABLE DATA DOES NOT CONFIRM INSULIN DELIVERY ON THE DATE OF DEATH, AND CLINICAL DETAILS ARE LIMITED; THEREFORE, A CAUSAL RELATIONSHIP BETWEEN ILET USE AND THE REPORTED DEATH CANNOT BE ESTABLISHED. BASED ON AVAILABLE INFORMATION, THE CAUSE OF THE EVENT REMAINS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 11-FEB-2026 IT WAS REPORTED THAT ON (B)(6) 2026 THE USER EXPERIENCED CARDIAC ARREST AND SUBSEQUENTLY DIED. EMERGENCY MEDICAL SERVICES RESPONDED, AND THE REPORTED CAUSE OF DEATH WAS CORONARY SYNDROME. THE OUTCOME WAS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235169 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080183

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Death DEXCOM G7 CGM