BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19902892 · Received August 4, 2024

    Report

    Report Number
    3003442380-2024-19031
    Event Type
    Malfunction
    Date Received
    August 4, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018457
    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 1931595 - MDR 3003442380-2024-19031 - DEVICE 2 OF 3.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THREE INFUSION SETS GOT LEAKED INSULIN AT SITE ON (B)(6) 2024. THE INFUSION SET BEEN IN USE FOR 2 TO 3 DAYS. THE CUSTOMER'S BLOOD GLUCOSE AT TIME ISSUE NOTICED WAS 372MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370711 TRUSTEEL UNO CONTACT DETACH G29 80/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002834 6003196 05705244018457

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male