BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19678541 · Received July 5, 2024

    Report

    Report Number
    8021545-2024-12491
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 6, 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 1904881 - MDR 3003442380-2024-12491 - DEVICE 4 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES , ON (B)(6) 2024, IT WAS REPORTED THAT SIX INFUSION SET TUBING WAS LEAKING AT SITE AND INFUSION SET IS LONG FOR 24 HOURS. THE BLOOD GLUCOSE LEVEL WAS 350-438 MG/DL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472961 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 33 YR Female