BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19475389 · Received June 6, 2024

    Report

    Report Number
    3003442380-2024-06664
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    April 24, 2024
    Report Date
    June 6, 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 1880738- DEVICE 2 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THE PATIENT FACED LEAKAGE AT SITE ON (B)(6) 2024 AND (B)(6) 2024. THE BLOOD GLUCOSE LEVEL OF THE PATIENT AT THE TIME OF ISSUE WAS 240 MG/DL. THE ISSUE OCCURRED WITH TWO SIMILAR TYPES OF INFUSION SETS USED FORTHREE AND HALF DAYS FOR ONE EVENT AND 15 HOURS FOR OTHER EVENT. .NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2792 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6000294 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male