BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TOUCH II

    MDR report key: 1070104 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05162
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET PROTRUDES FORM THE END CAP OF THE SOFT TOUCH 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 SOFT TOUCH II LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ACTOS 30MG DAILY 3 YEARS| BENICAR 20/12.5 TAB DAILY - 2 YEARS| ZOCOR 40MG DAILY 2 YEARS| SINGULAR 10MG DAILY - 7 YEARS| GLUCOVANCE 5/500MG 4/DAILY 12 YEARS