BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19475010 · Received June 6, 2024

    Report

    Report Number
    3003442380-2024-06649
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    February 23, 2024
    Report Date
    June 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016958
    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 1880701-MDR 3003442380-2024-06649- DEVICE 2 OF 4.

    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 WITHIN PAST TWO MONTHS. THE BLOOD GLUCOSE LEVEL OF THE PATIENT AT THE TIME OF ISSUE RANGED BETWEEN 250 TO 260 MG/DL. THE ISSUE OCCURRED WITH FOUR SIMILAR TYPES OF INFUSION SETS USED FOR TWO DAYS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980195 AUTOSOFT XC UNO INSET I 110/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001729 6002406 05705244016958

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male