BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23006581 · Received September 9, 2025

    Report

    Report Number
    3019004087-2025-02390
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 9, 2025
    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

    ON 13-AUG-2025 THE USER REPORTED EXPERIENCING HYPOGLYCEMIA WITH A BLOOD GLUCOSE OF 63 MG/DL. THE USER WAS ABLE TO TREAT THE HYPOGLYCEMIA BY CONSUMING FAST-ACTING ORAL CARBOHYDRATES. THE USER REPORTED THEY WERE STABLE FOLLOWING TREATMENT.

    Description of Event or Problem · 0

    ON 13-AUG-2025 THE USER REPORTED EXPERIENCING HYPOGLYCEMIA WITH A BLOOD GLUCOSE OF 63 MG/DL. THE USER WAS ABLE TO TREAT THE HYPOGLYCEMIA BY CONSUMING FAST-ACTING ORAL CARBOHYDRATES. THE USER REPORTED THEY WERE STABLE FOLLOWING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2824471 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG BETA BIONICS INC BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other