BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22998826 · Received September 8, 2025

    Report

    Report Number
    3019004087-2025-02319
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 8, 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

    AT THE TIME OF THIS REPORT THE ILET EVALUATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ON 11-AUG-2025 THE USER REPORTED THAT ON (B)(6) 2025 THEY EXPERIENCED HYPOGLYCEMIA WITH A BLOOD GLUCOSE OF 40 MG/DL. THE USER WAS IN FLORIDA SPENDING TIME WITH HER FAMILY AND WAS NOT EATING CONSISTENT MEALS, MISSING MEAL ANNOUNCEMENTS, AND ANNOUNCING MEALS LATE. THE USER WAS ABLE TO TREAT THE LOW BLOOD GLUCOSE BY EATING GUMMIES WITHOUT OUTSIDE ASSISTANCE. NO EMERGENCY MEDICAL SERVICES OR HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2497392 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention