BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1772021 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08187
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    September 2, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET WILL NOT RETRACT BACK INTO THE SOFTCLIX DEVICE AFTER FIRING. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS WIP125

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR ZETIA - 10 MG IN AM - 2-3 MONTHS| LIRICA - 75 MG TWICE DAILY - 7-8 YEARS| QUALAQUIN - 324 MG AS NEEDED - 7-8 YEARS| LASIX - 40 MG IN AM - 7-8 YEARS| DIOVAN - 160 MG IN AM - 7-8 YEARS