BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22931555 · Received September 2, 2025

    Report

    Report Number
    3019004087-2025-01780
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 3, 2025
    Report Date
    August 31, 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 CAREGIVER REPORTED RECEIVING AN ¿UNABLE TO PROCEED¿ ALERT ON THE ILET DEVICE DURING A SUPPLY CHANGE WHILE FILLING TUBING. MULTIPLE RESTARTS WERE ATTEMPTED, AND A SUBSEQUENT DRY RUN COMPLETED WITHOUT ISSUE. A FULL SUPPLY CHANGE WITH NEW SUPPLIES WAS PERFORMED, AND INSULIN DELIVERY RESUMED. REPLACEMENT SUPPLIES WERE ARRANGED. BLOOD GLUCOSE WAS NOT AFFECTED. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2865959 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DEXCOM G7 CGM, CONVATEC INSET (23", 6MM).