BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19490874 · Received June 7, 2024

    Report

    Report Number
    3003442380-2024-07056
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 7, 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 1881969 - DEVICE 3 OF 3. PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED AN ISSUE WITH THREE INFUSIONS SET TUBING WAS LEAKING ON (B)(6) 2024, (B)(6) 2024, AND (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 4-5 HOURS. THE BLOOD GLUCOSE LEVEL AT TIME OF EVENT WAS HIGH AND VALUED AS 200-328MG/DL. THE REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310386 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003998 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female