BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19847827 · Received July 28, 2024

    Report

    Report Number
    3003442380-2024-17539
    Event Type
    Malfunction
    Date Received
    July 28, 2024
    Date of Event
    April 21, 2024
    Report Date
    July 28, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1924715 - MDR 3003442380- 2024 - 17539 - DEVICE 5 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, IT WAS REPORTED THAT ON (B)(6) 2024 FIVE INFUSION SET FELL OFF DURING USE AND INFUSION SET IS USED FOR LESS THAN 24 HOURS TO A DAY. THE BLOOD GLUCOSE LEVEL WAS 300-400 MG/DL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529172 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 6004917

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female