BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22986690 · Received September 5, 2025

    Report

    Report Number
    3019004087-2025-02217
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 5, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    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 PERSISTENT HYPERGLYCEMIA UP TO 421 MG/DL DESPITE TWO SUPPLY CHANGES. AFTER SWITCHING TO A REPLACEMENT INFUSION SET, GLUCOSE DECREASED. BY (B)(6) 2025, THE USER¿S BG RETURNED TO NORMAL. NO EMS OR HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265907 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 CONTACT DETACH (23", 6MM)