BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1763613 · Received June 3, 2007

    Report

    Report Number
    1823260-2007-05794
    Event Type
    Malfunction
    Date Received
    June 3, 2007
    Date of Event
    June 25, 2007
    Report Date
    July 3, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING DISCREPANT RESULTS FOR TOXOPLASMOSIS LGM WHEN COMPARING 3 DIFFERENT METHODS. THE FOLLOWING EXAMPLES WERE PROVIDED: SAMPLE 1, INITIAL RESULT NEGATIVE, REPEAT WITH 2 ADDITIONAL METHODOLOGIES WAS POSITIVE. SAMPLE 2, INITIAL RESULT NEGATIVE, REPEAT WITH 2 ADDITIONAL METHODS WAS POSITIVE WITH ONE METHOD AND NEGATIVE WITH THE SECOND METHOD. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER - JJE LGD ROCHE DIAGNOSTICS E170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA