BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010

    MDR report key: 852174 · Received May 17, 2007

    Report

    Report Number
    1823260-2007-04257
    Event Type
    Malfunction
    Date Received
    May 17, 2007
    Date of Event
    April 23, 2007
    Report Date
    May 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL TOXOPLASMOSIS LGM RESULT OF NEGATIVE. SAME SAMPLE TESTED USING DIFFERENT METHODOLOGY WAS DETERMINED TO BE POSITIVE. IF ADD'L INFO IS REC'D, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 2010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR