BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1011685 · Received March 10, 2008

    Report

    Report Number
    1823260-2008-02276
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    December 26, 2007
    Report Date
    March 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET PROTRUDES FROM THE END CAP OF 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR LOSARTAN - DOSE UNK 1 /DAY| METFORMIN - 1000 MG 2/DAY| HYDROCHLOROTHIAZIDE - 25 MG LONG TIME| SIMVASTATIN - 10 MG 1/DAY| LISINOPRIL - 40 MG 1/DAILY| TRAMADOL HCL - 100MG 4/DAY - 10 YEARS| BACLOFEN - 10MG 3/DAY| METOPROLOL TARTRATE - 100MG 2/DAY LONG TIME| NIFEDIPINE - 30 MG 1/DAY