BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23174251 · Received September 29, 2025

    Report

    Report Number
    3019004087-2025-03792
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    August 31, 2025
    Report Date
    September 29, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    PMA / PMN Number
    K231485
    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 31-AUG-2025, THE USER EXPERIENCED A LOW BLOOD GLUCOSE (BG) EVENT WITH A LOW BLOOD GLUCOSE (BG) OF 52 MG/DL. THE USER TREATED WITH CARBOHYDRATES EVERY 15 MINUTES UNTIL BLOOD GLUCOSE (BG) INCREASED TO 90 MG/DL AND CONFIRMED STABLE. BLOOD GLUCOSE (BG) WAS CORRECTED WITH CARBOHYDRATE INTAKE WHILE CONTINUING ILET INSULIN THERAPY. NO ALARMS, ALERTS, OR INFUSION ISSUES WERE NOTED. NO SYMPTOMS DURING THE EVENT, OUTSIDE ASSISTANCE, OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840145 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male