BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23104047 · Received September 20, 2025

    Report

    Report Number
    3019004087-2025-03181
    Event Type
    Malfunction
    Date Received
    September 20, 2025
    Date of Event
    August 24, 2025
    Report Date
    September 20, 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 AGENT DOCUMENTED THAT THE USER EXPERIENCED DIFFICULTY INSERTING A CONNECTOR DURING A SUPPLY CHANGE. THE ISSUE PERSISTED EVEN WITHOUT THE CARTRIDGE, BUT THE USER WAS ABLE TO CONTINUE AFTER RECEIVING A NEW CONNECTOR. THE USER REPORTED THAT THIS COULD BE MANAGED FROM THAT POINT ONWARD. BLOOD GLUCOSE (BG) WAS NOT AFFECTED BY THIS EVENT, AND NO MEDICAL INTERVENTION IS REQUIRED AT THE TIME OF CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094981 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male