BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19946347 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-20377
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 9, 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 1934194 - MDR 3003442380-2024-20377 - DEVICE 3 OF 4.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED SIMILAR EVENTS WITH FOUR INFUSION SETS WHERE INFUSION SET TUBING HUB. TUBING HUB HAD A CUT/CRACK. THE INFUSION SET WERE IN USE FOR 24 HOURS EACH. PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS 300 MG/DL AND PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561511 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6003280 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male