BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23005619 · Received September 9, 2025

    Report

    Report Number
    3019004087-2025-02381
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 9, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Product Problem
    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 (B)(6) 2025, THE USER¿S MOTHER REPORTED A CONTINUOUS GLUCOSE MONITOR (CGM) OFFLINE ¿ "DOSING STOPS IN 7 HOURS" ALERT AFTER THE USER RAN OUT OF DEXCOM G7 SENSORS, CAUSING THE ILET TO SWITCH TO BLOOD GLUCOSE (BG) "RUN MODE". WHEN SHE MANUALLY ENTERED A BG VALUE, A "CALIBRATION NOT USED" ALERT APPEARED. BG WAS 287 MG/DL AT THE TIME OF THE CALL, AND NEW SENSORS WERE EXPECTED THE NEXT DAY. THE AGENT ADVISED WAITING THE HOUR INDICATED BY THE ALERT, MONITORING BG EVERY 30 MINUTES, AND USING BACKUP THERAPY IF NEEDED, WITH PLANS TO FOLLOW UP IN ONE HOUR. DURING THE EVENT, THE USER EXPERIENCED STOMACHACHE. THE USER WAS OUT OF BG RANGE FOR 90+ MINUTES; HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED AT THE TIME OF THE CALL. ON THE FOLLOW-UP ATTEMPT, THE PHONE NUMBER WAS OUT OF SERVICE, AND NO ALTERNATIVE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2824406 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female DEXCOM G7 CGM.