BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23164000 · Received September 28, 2025

    Report

    Report Number
    3019004087-2025-03738
    Event Type
    Malfunction
    Date Received
    September 28, 2025
    Date of Event
    August 30, 2025
    Report Date
    September 28, 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 REPORTED THAT DURING A SUPPLY CHANGE, A POSSIBLE INSULIN LEAK WAS NOTED. THE USER ELECTED TO WAIT AND MONITOR RATHER THAN REPLACE SUPPLIES. BLOOD GLUCOSE LEVELS REMAINED UNAFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664003 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG BETA BIONICS INC BB1001

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female