BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23017001 · Received September 10, 2025

    Report

    Report Number
    3019004087-2025-02473
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 10, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    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, USER¿S PUMP STOPPED DELIVERING INSULIN, SHOWING AN ¿UNABLE TO PROCEED¿ ALERT AFTER A RECENT SUPPLY CHANGE, LEADING TO HIGH BG LEVELS. USER REVERTED TO MULTIPLE DAILY INJECTION (MDI) DUE TO TIME CONSTRAINTS AND PLANNED TO CALL BACK FOR FURTHER ASSISTANCE. TROUBLESHOOTING WAS NOT COMPLETED, AND NO BLOOD GLUCOSE QUESTIONNAIRES (BGQ) OR LOT NUMBERS WERE GATHERED. FOLLOW-UP ATTEMPTS ON 18-AUG, 19-AUG, AND 20-AUG-2025 REACHED NO ANSWER, WITH VOICEMAILS LEFT EACH TIME. UNABLE TO REACH THE USER, IT IS NOT KNOWN IF THE USER EXPERIENCED ANY SYMPTOMS DURING THE EVENT AND IF ANY MEDICAL INTERVENTION WAS PERFORMED AT THE TIME OF CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446349 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other MULTIPLE DAILY INJECTION (MDI)