BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19737793 · Received July 14, 2024

    Report

    Report Number
    3003442380-2024-14142
    Event Type
    Malfunction
    Date Received
    July 14, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 14, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018488
    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 (B)(4). - MDR DEVICE 2 OF 8.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED 8 INFUSION SET LEAKAGE EVENT FROM 24-MAY-2024 TO 06-JUN-2024. THE INFUSION SET WAS IN USE FOR 24 HOURS. THE LEAKAGE WAS AT SITE. THE GLUCOSE LEVEL WAS 300 MG/DL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210936 TRUSTEEL UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL A/S 1002835 605231 05705244018488

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male