BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX® LANCET DEVICE

    MDR report key: 1942389 · Received December 30, 2010

    Report

    Report Number
    1823260-2010-07764
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 25, 2010
    Report Date
    February 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE NEEDLE FROM THE SOFTCLIX LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX® LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAV099

    Patients

    Seq Age Sex Outcome Treatment
    1