BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19558123 · Received June 18, 2024

    Report

    Report Number
    3003442380-2024-08820
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    April 19, 2024
    Report Date
    June 19, 2024
    Manufacturer
    UNOMEDICAL A/S
    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 1890567- DEVICE 3 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON 19-APRIL-2024, IT WAS REPORTED BY THE PATIENT THAT SIX INFUSIONS SET FELL OFF DUE TO WHICH HYPERGLYCEMIA OCCURS WITHIN ONE DAYS OF USE. HIGH BLOOD GLUCOSE LEVEL WAS 270 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315593 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 UNKNOWN 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male