BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO INSET II 60/6 BLUE TCAP 10PK INT

    MDR report key: 19678360 · Received July 5, 2024

    Report

    Report Number
    3003442380-2024-12288
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018303
    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 1903609- MDR 3003442380-2024-12288- 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 INFUSION SET FELL OFF DURING USE. CALLER REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133797 UNO INSET II 60/6 BLUE TCAP 10PK INT AUTOSOFT 90 FPA UNOMEDICAL A/S 1002823 UNKNOWN 05705244018303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose