BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19728572 · Received July 12, 2024

    Report

    Report Number
    3003442380-2024-13615
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    May 18, 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 (B)(4). - MDR DEVICE 1 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SETS FELL OFF DURING USE EVENTS ON 20-MAY-2024, 23-MAY-2024, AND 30-MAY-2024. THE INFUSION SET WAS USED FOR 3 - 4, 23, AND 36 HOURS ON 20-MAY-2024, 23-MAY-2024, AND 30-MAY-2024. THE BLOOD GLUCOSE LEVEL WAS 120MG/DL. THE PATIENT RESOLVED THE EVENT BY REPLACING THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275284 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 UNKNOWN 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male