BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1771990 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08177
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    September 2, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE LANCET NEEDLE DID NOT RETRACT AFTER FIRING IN THE SOFTCLIX LANCET DEVICE. NO ACCIDENTAL STICKS 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 LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS WIR107

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR ACTOS - 1.5 YEARS, 30MG/DAILY| METFORMIN - 3 YEARS, 1000MG/DAILY