BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1221500 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08190
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 9, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED A DISCREPANT POSITIVE RESULT FOR TOXOPLASMOSIS IGG. IT IS UNKNOWN IF ERRONEOUS RESULT WAS REPORTED. USER DOES NOT STATE THE PATIENT WAS ADVERSELY AFFECTED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER - CEM LGD ROCHE DIAGNOSTICS C601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK