BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO INSET I 60/6 GREY TCAP 10PK INT

    MDR report key: 19567154 · Received June 19, 2024

    Report

    Report Number
    3003442380-2024-09049
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    January 1, 2024
    Report Date
    June 19, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1890695 - MDR 3003442380-2024-08827- DEVICE 1 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT INFUSION SET TUBING WAS LEAKING AT SITE LOCATION FOR 15 INFUSION SETS WHICH LED TO HIGH BG (535 MG/DL). THE INFUSION SET WAS IN USE FOR 2DAYS.PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549032 UNO INSET I 60/6 GREY TCAP 10PK INT AUTOSOFT XC FPA UNOMEDICAL A/S 1001680 UNKNOWN 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female