BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1772005 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08163
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    September 14, 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
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE LANCET DOES NOT RETRACT INTO THE SOFTCLIX LANCET DEVICE AFTER FIRING. NO ADVERSE EVENT REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. 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 47 YR GLUCOPHAGE - 2000MG/DAY| GLIPIZIDE - 10MG/DAY