BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19574059 · Received June 20, 2024

    Report

    Report Number
    3003442380-2024-09292
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    April 14, 2024
    Report Date
    June 20, 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 1891667 - MDR 3003442380-2024-09292- DEVICE 3 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET WAS LEAKING AT SITE FROM (B)(6) 2024. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS AROUND 296 MG/DL. THE ISSUE OCCURRED WITH FIVE SIMILAR TYPES OF INFUSION SET USED FO ONE TO TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155759 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003726 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female