BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1040955 · Received May 2, 2008

    Report

    Report Number
    1823260-2008-03708
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET PROTRUDING FROM END CAP OF SOFTCLIX PLUS DEVICE. AFTER SEVERAL ATTEMPTS TO REACH CUSTOMER, MFR WAS UNABLE TO DETERMINE IS LANCET FAILED TO RETRACT PRIOR TO OR AFTER FIRING. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE PRODUCT, 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR ACTOS 45MG/DAY