BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19663642 · Received July 3, 2024

    Report

    Report Number
    3003442380-2024-11703
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    May 7, 2024
    Report Date
    November 24, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1901074- MDR 3003442380-2024- 11703- DEVICE 1 OF 2 PATIENT COUNTRY: (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED KINGDOM. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT TWO INFUSION SET TUBING DETACHED FROM CONNECTOR DUE TO WHICH HYPERGLYCEMIA OCCURS WITHIN 24 HOURS OF USE. HIGH BLOOD GLUCOSE LEVEL WAS 13MMOL/L. EVENT OCCURRED ON 05/23/2024 AND 05/07/2024. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800177 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 6003839 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown