BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1760952 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06187
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 21, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE LANCET DOES NOT FULLY RETRACT INSIDE OF THE SOFTCLIX LANCET DEVICE AFTER FIRING. NO UNINTENTIONAL PUNCTURE WAS REPORTED. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    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 50 YR METFORMIN 500 MG - ONCE DAILY