BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1761212 · Received July 23, 2007

    Report

    Report Number
    1823260-2007-06395
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 12, 2007
    Report Date
    July 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CUSTOMER DID NOT RECALL IF IT HAPPENED BEFORE OR AFTER FIRING 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 DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR COUMADIN - 3 YRS, 6MG/DAY| PRANDIN - 3MOS, 3MG/DAY| NIASPAN - 1MO, 500MG/DAY| CLONAZEPAM - 5YRS, .5MG/DAY| GABAPENTIN - 5MOS, 600MG/DAY| COREG - 5 YRS, 25MG/DAY| ASPIRIN - 5 YRS, 81MG /DAY| DIGITEX - 4 YRS, .125MG/DAY| TRICOR - 5YRS, 45MG/DAY| SIMVASTATIN - 5YRS, 10MG/DAY| METHOCARBAMOL - 4MOS, 500MG/AS NEEDED