BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1761025 · Received July 13, 2007

    Report

    Report Number
    1823260-2007-06111
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 13, 2007
    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 LANCET NEEDLE THAT IS A PART OF THE SOFTCLIX LANCING SYSTEM WOULD NOT RETRACT AFTER USE. REPORTER STATED AFTER USING THE LANCING SYSTEM, THE NEEDLE REMAINED PROTRUDING OUTWARDS 1/8TH OF AN INCH. NO ACTIONS WERE TAKEN OR TREATMENT 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR