BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1002098 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01719
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED, THE NEEDLE FROM THE SOFTCLIX PLUS LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP AFTER IT HAS BEEN FIRED. REPORTER STATED, THAT HE DID ACCIDENTALLY STICK HIMSELF WITH THE PROTRUDING LANCET. NO ACTIONS OR TREATMENTS WERE REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 72 YR DIOVAN -2 YRS 160 MG TWICE DAILY| NOVOLIN - 70/30 10 YRS 60 UNITS TWICE DAILY| ASPIRIN - 4 YRS 81 MG ONCE DAILY| POTASSIUM - 3-4 YRS 10 MG ONCE DAILY| FUROSEMIDE - 4 YRS 40 MG ONCE DAILY| ENALAPRIL - 4 YRS 20 MG TWICE DAILY| COREG - 2 YRS 12.5 MG TWICE DAILY| METFORMIN - 3 YRS 850 MG 3 TIMES DAILY| VYTORIN - 1 YR 10/40 MG ONCE DAILY