BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1063761 · Received June 19, 2008

    Report

    Report Number
    1823260-2008-04844
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 19, 2008
    Manufacturer
    ROCHE DIAGNOSTIC
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE LANCET DOES NOT RETRACT INTO THE SOFTCLIX PLUS LANCET DEVICE. 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 PLUS LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTIC BAT020

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR GAVISCON - 10YRS 1 TBLSP AS NEEDED| HYDRODIURIL - 10YRS 25MG/DAY| CELEBREX - 10YRS 200MG/DAY| ECOTRIN - 12YRS 325MG/DAY| CHOLESTYRAMINE - 2YRS| REQUIP - 1 1/2 YEAR 2MG/DAY| NITROGLYCERIN - 12YRS 0.4MG AS NEEDED| RISPERDAL - 40YRS 0.1MG/DAY| ZETIA - 1 1/2 YEAR 10MG/DAY| SYSTANE - 2YRS| PROVENTIL - 1 1/2 YEAR| PROTONIX - 4YRS 40MG/DAY| NITROGLYCERIN PATCH - 12YRS 2.2MG/DAY 12 HOURS| NEURONTIN - 10YRS 4800MG/DAY| LEVSIN - 10YRS 0.125MG/4 HOURS| LASIX - 5YRS 40MG/DAY| NOVOLIN R - 6 MONTHS 18 UNITS/DAY| FLONASE - 2YRS| CYMBALTA - 2YRS 60MG/DAY| AMBIEN - 3YRS 5MG/DAY| LIPITOR - 10YRS 20MG/DAY| VICODIN - 20YRS AS NEEDED| PLAVIX - 12YRS 75MG/DAY| NOVOLIN N - 6 MONTHS 25 UNITS/DAY| ATIVAN - 3YRS 0.5MG/DAY| MICRO K - 40YRS 10MG DAILY