BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS E MODULE

    MDR report key: 1336568 · Received March 10, 2009

    Report

    Report Number
    1823260-2007-05060
    Event Type
    Malfunction
    Date Received
    March 10, 2009
    Date of Event
    March 16, 2007
    Report Date
    June 11, 2007
    Manufacturer
    ROCHE DIAGONOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2007, INITIAL RESULT OF POSITIVE FOR TOXOPLASMOSIS LGG. SAME SAMPLE REPEATED USING 2 DIFFERENT METHODS RECOVERED NEGATIVE. A SECOND SAMPLE DRAWN FROM THE SAME PATIENT AT ABOUT 12 DAYS LATER WAS POSITIVE WHEN INITIALLY TESTED, AND NEGATIVE WHEN REPEATED USING 2 DIFFERENT METHODS. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGONOSTICS E170

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR