BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1770876 · Received November 12, 2007

    Report

    Report Number
    1823260-2007-09827
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 23, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET STICKS OUT AFTER BEING FIRED WHILE USING THE SOFTCLIX PLUS LANCET DEVICE. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE 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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR GLIPIZIDE 20 MG 2X/DAY - 1 WEEK| DIOVAN 80MG/DAY - 2 DAYS| FLOMAX 0.4MG/DAY - 2 YEARS| ASPIRIN 81MG DAILY - 2-3 YEARS| CADUET 10/40MG/DAY - 2 YEARS