BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1973075 · Received January 28, 2011

    Report

    Report Number
    1823260-2011-00506
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    September 13, 2010
    Report Date
    May 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. THE SAMPLES WERE FOUND CLEARLY POSITIVE FOR ANTI-TOXO IGG WITH THE ELECSYS. THIS WAS FURTHER CONFIRMED BY A VALIDATED NEUTRALIZATION ASSAY. DIFFERENT CONCENTRATION VALUES DERIVED BY DIFFERENT TEST FORMATS ARE OFTEN OBSERVED IN TOXOPLASMA IGG SEROLOGY. IT WAS DETERMINED THE POSITIVE ELECSYS RESULT WAS CORRECT. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE TOXOPLASMA IGG RESULTS FOR THREE SAMPLES FROM ONE PREGNANT PATIENT WHO WAS KNOWN AS NEGATIVE FOR TOXOPLASMA IGG AND IGM WITH VIDAS AND PLATELLIA BIORAD METHODS. THE RESULT FROM THE FIRST SAMPLE ON (B)(6) 2010 WAS 92 U/ML AND THE RESULT FROM THE VIDAS WAS NEGATIVE. THE RESULT FROM THE SECOND SAMPLE ON (B)(6) 2010 WAS 49 U/ML AND THE RESULTS FROM THE VIDAS AND PLATELLIA METHODS WERE NEGATIVE AT 4.2 U/ML WITH A CUT OFF AT 9 U/ML. THE WESTERN BLOT WAS NEGATIVE AND THE RESULT BY ABBOTT METHOD WAS 2.1 AND 2.2 (NO UNIT OF MEASURE WAS PROVIDED) OR INDETERMINATE. THE RESULT FROM THE THIRD SAMPLE ON (B)(6) 2011 WAS 49 U/ML AND THE RESULT FROM THE VIDAS WAS NEGATIVE. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE TOXOPLASMA IGG REAGENT LOT NUMBER WAS 160206.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 035 YR