BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1023840 · Received April 2, 2008

    Report

    Report Number
    1823260-2008-02921
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET PROTRUDES FROM THE END OF THE SOFTCLIX PLUS 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 PLUS LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR LISINOPRIL 10MG ONCE DAILY| GLIPIZIDE 4MG TWICE DAILY| "FOLPEX" DOSE UNK DAILY 10 YEARS| CRESTOR 10MG ONCE DAILY| "DOEPIZOXEPI" 10MG DAILY| TOPROL 100MG ONCE DAILY| CYMBALTA 60MG DAILY| IODINE ONCE DAILY - 4.5 MONTHS| UNK PATCHCES ON BACK/PAIN| ALLEGRA 60MG TWICE DAILY| TOPAMAX 10MG ONCE DAILY 10 YEARS