BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19678505 · Received July 5, 2024

    Report

    Report Number
    3003442380-2024-12399
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    March 29, 2024
    Report Date
    July 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1904660 - MDR 3003442380-2024-12399 - DEVICE 3 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES , ON (B)(6) 2024, IT WAS REPORTED THAT THREE INFUSION SET WAS LEAKING AT SITE AND INFUSION SET IS USE FOR LESS THAN 2-3 DAYS. THE BLOOD GLUCOSE LEVEL WAS HIGH, AND THE ISSUE IS OCCURRING DUE TO CORRECTION BOLUS VIA PUMP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446913 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003742 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male