BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1181030 · Received September 29, 2008

    Report

    Report Number
    1823260-2008-07234
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET PROTRUDING FROM END CAP OF SOFTCLIX DEVICE. MANUFACTURER'S AGENT WAS UNABLE TO DETERMINE FROM THE CUSTOMER IF LANCET FAILED TO RETRACT PRIOR TO OR AFTER FIRING. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK