BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 20047525 · Received August 23, 2024

    Report

    Report Number
    3003442380-2024-22400
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 20, 2024
    Report Date
    July 26, 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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED AN EVENT OF OCCLUSION AT INFUSION SET SITE ON (B)(6) 2024. BLOOD GLUCOSE LEVEL WAS DISPLAYED HIG AT TIME OF THE EVENT. THEREFORE, PATIENT TOOK CORRECTION BOLUS VIA PUMP. INFUSION SET WAS USED FOR MORE THAN 48 HOURS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313194 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 6005228 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male