BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1022813 · Received March 28, 2008

    Report

    Report Number
    1823260-2008-02837
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET STICKS OUT WHILE USING THE SOFTCLIX PLUS LANCET DEVICE. NO INFORMATION WAS PROVIDED ON WHETHER LANCET PROTRUDED BEFORE OR AFTER FIRING. NO ACCIDENTAL STICK REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX PLUS LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS WIN459

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR