BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23126846 · Received September 23, 2025

    Report

    Report Number
    3019004087-2025-03403
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 23, 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 26-AUG-2025 THE USER REPORTED AN OCCLUSION ALERT (ALERT 35) ON THE ILET. NO ADDITIONAL INFORMATION, BLOOD GLUCOSE VALUES, OR HEALTH EFFECTS WERE OBTAINED. NO FURTHER DETAILS WERE PROVIDED, AND FOLLOW-UP ATTEMPTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201405 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABBOTT FREESTYLE LIBRE 3+ CGM.