BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24729438 · Received March 30, 2026

    Report

    Report Number
    3019004087-2026-40022
    Event Type
    Death
    Date Received
    March 30, 2026
    Date of Event
    July 30, 2024
    Report Date
    March 30, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080190
    PMA / PMN Number
    K231485
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER WAS REPORTED TO HAVE DIED FOLLOWING A HYPOGLYCEMIC EVENT WHILE USING THE ILET. 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 HYPOGLYCEMIA PRIOR TO CGM SENSOR FAILURE ON THE NIGHT OF THE EVENT, WITH APPROPRIATE REDUCTION AND SUSPENSION OF INSULIN DELIVERY AND REPEATED LOW GLUCOSE ALERTS. THE LAST LOGGED INTERACTION WAS AN INFUSION SET CHANGE PRIOR TO THE USER BEING FOUND DECEASED. DUE TO LOSS OF CGM DATA AND LACK OF ADDITIONAL CLINICAL OR SITUATIONAL DETAILS, IT CANNOT BE DETERMINED WHETHER THE HYPOGLYCEMIA OCCURRED BEFORE OR AFTER THE USER¿S DEATH OR WHETHER THE EVENT WAS RELATED TO ILET USE. BASED ON AVAILABLE INFORMATION, A CAUSAL RELATIONSHIP BETWEEN ILET USE AND THE REPORTED DEATH CANNOT BE ESTABLISHED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THIS MDR IS PART OF A REMEDIAL SUBMISSION MADE IN RESPONSE TO FDA FORM 483 OBSERVATIONS TO ENSURE FULL REPORTING COMPLIANCE.

    Description of Event or Problem · 0

    ON 29-APR-2025 IT WAS REPORTED THAT ON (B)(6) 2024, THE USER DIED FOLLOWING A REPORTED HYPOGLYCEMIC EVENT OVERNIGHT. EMERGENCY SERVICES WERE CONTACTED, AND NO TREATMENT DETAILS WERE REPORTED. THE OUTCOME WAS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793803 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Death