BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24301144 · Received February 10, 2026

    Report

    Report Number
    3019004087-2026-28217
    Event Type
    Death
    Date Received
    February 10, 2026
    Date of Event
    January 1, 2026
    Report Date
    February 9, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER DEATH OCCURRED WHILE THE USER WAS WEARING THE ILET; HOWEVER, AVAILABLE INFORMATION DOES NOT ESTABLISH A CAUSAL RELATIONSHIP BETWEEN THE ILET AND THE REPORTED DEATH. ENGINEERING LOG REVIEW WAS LIMITED BECAUSE THE DEVICE WAS SHUT DOWN AT 04:33 ON (B)(6) 2026 VIA A SHUTDOWN REQUEST AND WAS NOT POWERED ON AGAIN UNTIL (B)(6) 2026. NO MALFUNCTION ALERTS OR FACTORY RESETS WERE IDENTIFIED IN THE AVAILABLE ENGINEERING LOGS. DEVICE DATA SHOWED CGM GLUCOSE VALUES WERE IN OR SLIGHTLY ABOVE RANGE PRIOR TO THE EVENT, WITH REPEATED DEXCOM G7 ¿BRIEF SENSOR ISSUES¿ BEGINNING THE EVENING OF (B)(6) 2025, FOLLOWED BY ¿SENSOR FAILED¿ AT 01:16 ON (B)(6) 2026, INITIATION OF BG RUN, AND A ¿DOSING STOPS SOON¿ ALERT PRIOR TO DEVICE SHUTDOWN. BASED ON AVAILABLE INFORMATION, THE CAUSE OF DEATH REMAINS UNCLEAR PENDING AUTOPSY, AND A DEVICE-RELATED CAUSE COULD NOT BE ESTABLISHED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 14-JAN-2026 IT WAS REPORTED THAT ON (B)(6) 2026 THE USER WAS FOUND UNRESPONSIVE AT HOME AND WAS PRONOUNCED DECEASED BY EMERGENCY MEDICAL SERVICES AT APPROXIMATELY (B)(6) 2026. THE USER HAD BEEN EVALUATED AT THE HOSPITAL ON (B)(6) 2025 FOR NEUROLOGICAL SYMPTOMS AND DISCHARGED (B)(6) 2025. THE CAUSE OF DEATH IS UNKNOWN AND PENDING AUTOPSY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362915 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080183

    Patients

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