BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19672650 · Received July 3, 2024

    Report

    Report Number
    3003442380-2024-11630
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    May 18, 2024
    Report Date
    July 4, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    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 1901859 - MDR 3003442380-2024-11630 - DEVICE 1 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 18-MAY-2024, IT WAS REPORTED THAT THE FOUR INFUSION SET LEAKING WAS INSERTION AT SITE AND INFUSION SET IS LONG FOR 16 HOURS. THE BLOOD GLUCOSE LEVEL WAS 172 MG/DL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565804 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 5408371 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female