BEUDAMED
    FDA Adverse Event Injury Summary report: N

    00430829

    MDR report key: 23323931 · Received October 17, 2025

    Report

    Report Number
    3019004087-2025-05362
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 21, 2025
    Report Date
    October 17, 2025
    Manufacturer
    BETA BIONICS INC
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    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 ELEVATED BLOOD GLUCOSE (BG) READINGS OF 300¿372 MG/DL AFTER EATING CHINESE FOOD AND BBQ PORK. THE USER WAS INITIALLY UNABLE TO PROCEED WITH INSULIN DELIVERY BUT, AFTER PERFORMING FOUR DRY RUNS WITH GUIDANCE FROM BETA BIONICS CUSTOMER SUPPORT, WAS ABLE TO RESUME PUMP THERAPY SUCCESSFULLY. NO HOSPITALIZATION OR ADVERSE HEALTH EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821281 00430829 ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG BETA BIONICS INC BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other