BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19936587 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-19557
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    June 29, 2024
    Report Date
    July 9, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244021099
    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 1933987 - MDR 3003442380-2024-19557 - DEVICE 2 OF 2.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SETS FELL OFF DURING USE EVENT ON 29-JUN-2024. THE INFUSION SET WAS IN USE FOR 1 DAY. THE BLOOD GLUCOSE LEVEL AT THE TIME OF EVENTS WAS 110 MG/DL AND PATIENT RESOLVED THE EVENT BY REPLACING INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394172 AUTOSOFT XC UNO INSET I 80/6 GREY TCAP 10PACK US FPA UNOMEDICAL A/S 1003912 6004992 05705244021099

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male