BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2328891 · Received November 9, 2011

    Report

    Report Number
    1823260-2011-06081
    Event Type
    Malfunction
    Date Received
    November 9, 2011
    Date of Event
    October 14, 2011
    Report Date
    March 29, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE IN QUESTION WAS INVESTIGATED AND THE USER'S RESULTS COULD BE CONFIRMED BY USING TWO DIFFERENT LOTS OF TOXOPLASMA IGG REAGENT AND NEUTRALIZATION TESTING. THEREFORE, THE POSITIVE RESULT FOR THE PATIENT SAMPLE WAS REGARDED AS CORRECT. DIFFERENT CONCENTRATION VALUES DERIVED BY DIFFERENT TEST FORMATS ARE OFTEN OBSERVED IN TOXOPLASMA IGG SEROLOGY ALTHOUGH MOST OF THE TESTS ARE STANDARDIZED AGAINST THE WHO-STANDARD. THEREFORE, A DISCREPANT RESULT COMPARED TO A COMPETITOR METHOD IS NOT UNUSUAL DUE TO THE DESIGNED HIGHER SENSITIVITY OF THE TEST FORMAT.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE POSITIVE TOXOPLASMA IGG RESULT FOR ONE PATIENT. ALL RESULTS ARE IN IU/ML. THE INITIAL RESULT WAS 54.2 (POSITIVE) AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON AN ABBOTT AXSYM ANALYZER AND THE RESULT WAS 1.3 (NEGATIVE). THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TOXOPLASMA IGG REAGENT LOT NUMBER WAS 163699. THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR