BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19835259 · Received July 26, 2024

    Report

    Report Number
    8021545-2024-02617
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 26, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018877
    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 1922442- MDR 8021545-2024-02617 - DEVICE 6 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED 6 INFUSION SETS LEAKAGE EVENT THAT BEGAN ON 20-JUN-2024. THE LEAKAGE WAS LOCATED AT THE SITE. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 386 MG/DL, THE EVENT OF LEAKAGE WAS RESOLVED BY REPLACING INFUSION SET AND RESULMIG INSULIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946260 TRUSTEEL UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL A/S 1002835 6004744 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male