BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19759415 · Received July 17, 2024

    Report

    Report Number
    3003442380-2024-14874
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 5, 2024
    Report Date
    October 28, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026001
    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 1913958- MDR 3003442380-2024-14874- 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 THE NEEDLE GUARD LEFT AND INFUSION SET WAS INSERTED. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 150 MG/DL. THE ISSUE OCCURRED WITH TWO SIMILAR TYPES OF INFUSION SETS USED FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748249 AUTOSOFT XC INSET I 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1010900 6004406 05705244026001

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female