BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOFT

    MDR report key: 19678524 · Received July 5, 2024

    Report

    Report Number
    8021545-2024-01698
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    May 21, 2024
    Report Date
    July 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018693
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1904819 - MDR 8021545-2024-01698 - DEVICE 3 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 21-MAY-2024, IT WAS REPORTED THAT THREE INFUSION SET TUBING WAS LEAKING AT SITE CONNECTOR AND INFUSION SET IS LONG FOR 2 DAYS. THE BLOOD GLUCOSE LEVEL WAS 330 MG/DL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447938 VARISOFT UNO COMFORT SHORT 60/13 TCAP 10PK INT FPA UNOMEDICAL A/S 1002827 UNKNOWN 05705244018693

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female