BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 14520194 · Received May 27, 2022

    Report

    Report Number
    3003442380-2022-00711
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Report Date
    May 27, 2022
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT'S INFUSION SET'S TUBING DETACHED/BROKEN AT SITE CONNECTOR AND THE PATIENT WAS NOT ABLE TO USE THE INFUSION SET. AT THE TIME OF THE EVENT, HER BLOOD GLUCOSE LEVEL WAS BETWEEN 103-147 MG/DL. MOREOVER, THEY REPLACED THE INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502548 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA 1002833 UNKNOWN 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown