BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24839434 · Received April 10, 2026

    Report

    Report Number
    3019004087-2026-42038
    Event Type
    Death
    Date Received
    April 10, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 10, 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

    NO DEVICE DEFICIENCY CAN BE ESTABLISHED AT THIS TIME. REVIEW OF AVAILABLE DEVICE DATA, INCLUDING ENGINEERING LOGS, CONFIRMED THAT THE ILET WAS OPERATING AS INTENDED WITH APPROPRIATE ALERTING AND INSULIN DELIVERY BEHAVIOR, AND NO MALFUNCTIONS, MOTOR ERRORS, OR ABNORMAL CONDITIONS WERE IDENTIFIED. A LIBRE 3+ CONTINUOUS GLUCOSE MONITORING SYSTEM WAS IN USE DURING THE EVENT PERIOD. THERE WAS NO EVIDENCE OF DEVICE-RELATED FAILURE, AND NO FACTORY RESET EVENTS WERE OBSERVED. THE USER¿S DEATH WAS REPORTED BY A FAMILY MEMBER; HOWEVER, NO CLINICAL DETAILS, CAUSE OF DEATH, BLOOD GLUCOSE VALUES, OR INFORMATION REGARDING MEDICAL INTERVENTION WERE PROVIDED DESPITE FOLLOW-UP ATTEMPTS. AS A RESULT, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT CANNOT BE DETERMINED. AT THIS TIME, THE COMPLAINT IS CONSIDERED UNCONFIRMED WITH RESPECT TO DEVICE PERFORMANCE. THE INVESTIGATION REMAINS INCONCLUSIVE DUE TO INSUFFICIENT INFORMATION, AND THE EVENT WILL BE DOCUMENTED AND TRENDED IN ACCORDANCE WITH RISK MANAGEMENT PROCEDURES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ON 18-MAR-2026, THE COMPANY REPRESENTATIVE REPORTED THAT ON (B)(6) 2026 THE USER EXPIRED WHILE USING THE ILET BIONIC PANCREAS SYSTEM. NO INFORMATION REGARDING BLOOD GLUCOSE (BG) VALUES, PRECEDING CONDITIONS, OR CONTRIBUTING FACTORS WAS PROVIDED. NO EMS OR HOSPITALIZATION DETAILS WERE REPORTED, AND OUTCOME WAS DEATH. LONG-TERM HEALTH EFFECTS ARE NOT APPLICABLE DUE TO FATAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900218 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Death FREESTYLE LIBRE 3+