BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19663023 · Received July 3, 2024

    Report

    Report Number
    3003442380-2024-11444
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    April 15, 2024
    Report Date
    July 3, 2024
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1900994 - MDR 3003442380-2024-11444 - DEVICE 2 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 15-APR-2024, IT WAS REPORTED THAT THE TWO INFUSION SET WAS FELL OFF DURING USE. THE INFUSION SET IS LONG FOR LESS THAN 3 HOURS. THE BLOOD GLUCOSE LEVEL WAS 389 MG/DL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551233 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA 1002833 6004163 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female