BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19517847 · Received June 12, 2024

    Report

    Report Number
    3003442380-2024-07708
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 2, 2024
    Report Date
    June 11, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026032
    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 1885069 - MDR 3003442380-2024-07708 - DEVICE 7 OF 7.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET FELL OFF DURING USE ON (B)(6) 2024. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS HIGH WHICH WAS TREATED BY CORRECTION BOLUS VIA PUMP. THE ISSUE OCCURRED WITH SEVEN TYPES OF INFUSION SETS USED FOR ONE TO THREE HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183231 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6003995 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female