BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19737313 · Received July 14, 2024

    Report

    Report Number
    3003442380-2024-14081
    Event Type
    Malfunction
    Date Received
    July 14, 2024
    Date of Event
    May 9, 2024
    Report Date
    July 14, 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 1912290 - MDR 3003442380-2024-14081 - DEVICE 2 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT BETWEEN (B)(6) 2024 THE PATIENT EXPERIENCED ISSUE WITH THREE INFUSION SETS WERE FELL OFF DURING USE. THE AREA OF INSERTION WAS CLEANED AND AIR-DRIED. THE INFUSION WAS SET IN USE FOR 1 DAY. THE BLOOD GLUCOSE LEVEL WAS 150 MG/DL. THE PATIENT REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257468 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6004231 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male