BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23145957 · Received September 25, 2025

    Report

    Report Number
    3019004087-2025-03561
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 25, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    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 RECEIVED AN "OCCLUSION" ALERT SHORTLY AFTER COMPLETING A SUPPLY CHANGE. BLOOD GLUCOSE (BG) WAS ELEVATED AT 397 MG/DL. THE AGENT ADVISED WAITING AN ADDITIONAL HOUR TO ALLOW BLOOD GLUCOSE (BG) TO RETURN TO RANGE. FOLLOW-UP CALLS ON 28-AUG-2025, 29-AUG-2025, AND 01-SEP-2025 WERE UNSUCCESSFUL, WITH NO MEANINGFUL UPDATES OBTAINED. OUTCOME OF THE ELEVATED BLOOD GLUCOSE (BG) EVENT REMAINS UNCONFIRMED. NO INFORMATION WAS RECEIVED ON THE SYMPTOMS EXPERIENCED BY THE USER DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642645 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female