BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1781014 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06542
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 10, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES LANCET WILL NOT RETRACT INTO THE SOFTCLIX DEVICE AFTER FIRING. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT RELATED TO THE DEVICE REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 85 YR GLYBURIDE 1.25MG 2-3/DAY