BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19727648 · Received July 12, 2024

    Report

    Report Number
    3003442380-2024-13821
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 1, 2024
    Report Date
    July 12, 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 1910343- MDR 3003442380-2024-13821- DEVICE 2 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT FOUR INFUSIONS SET FELL OFF DUE TO WHICH HYPERGLYCEMIA OCCURS WITHIN ONE DAY OF USE. HIGH BLOOD GLUCOSE LEVEL WAS 375 MG/DL. EVENT WAS OCCURRED ON (B)(6) 2024. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314986 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6004388 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male