BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19331861 · Received May 16, 2024

    Report

    Report Number
    3003442380-2024-02165
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Report Date
    May 16, 2024
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED BY THE PATIENT THAT THE INFUSION SET TUBING WAS DAMAGED WHERE IT CONNECTS TO CANNULA HOUSING. 4-5 HOURS THE INFUSION HAS BEEN IN USE.BLOOD GLUCOSE LEVEL WAS 150-270 MG/DL. NO FURTHER INFORMATION WAS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547009 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA 6003262 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown