BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19536179 · Received June 14, 2024

    Report

    Report Number
    3003442380-2024-08164
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    April 20, 2024
    Report Date
    June 14, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018457
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 2 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SET FELL OFF DURING USE EVENTS ON 20-APR-2024, 25-APR-2024 AND 03-MAY-2024. THE INFUSION SET WAS IN USE FOR 2 DAYS. THE BLOOD GLUCOSE LEVEL WAS 150 MG/DL. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393840 TRUSTEEL UNO CONTACT DETACH G29 80/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002834 6001643 05705244018457

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male