BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2063701 · Received April 20, 2011

    Report

    Report Number
    1823260-2011-02135
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 22, 2011
    Report Date
    January 5, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. INVESTIGATION OF THE SAMPLE WAS NOT POSSIBLE DUE TO INSUFFICIENT VOLUME.

    Description of Event or Problem · 1

    THE USER EXPERIENCED AN ISSUE WITH QUESTIONABLE HIGH FREE TRIIODOTHYRONINE (FT3) RESULTS FOR A PATIENT SAMPLE EVERY FOUR TO FIVE DAYS WHERE THE TSH RESULT WAS HIGH AND THE FT4 RESULT WAS NORMAL. DATA WAS PROVIDED FOR ONE PATIENT SAMPLE WITH DISCREPANT FT3 AND FREE THYROXINE (FT4) RESULTS. THE INITIAL FT3 RESULT WAS 7.98 PMOL/L AND THE REPEAT RESULT ON THE SAME ANALYZER WAS 8.03 PMOL/L. THE INITIAL FT4 RESULT WAS 13.65 AND THE REPEAT RESULT ON THE SAME ANALYZER WAS 13.36. NO UNIT OF MEASURE WAS PROVIDED. ON (B)(6) 2011, THE SAME SAMPLE WAS TESTED IN ANOTHER LABORATORY WITH TWO COBAS 6000 SYSTEMS. THE FT3 RESULT FROM COBAS I WAS 4.78 PG/ML AND THE RESULT FROM COBAS II WAS 4.64 PG/ML WITH A DATA FLAG. THE FT4 RESULT FROM COBAS II WAS 1.09. NO UNIT OF MEASURE WAS PROVIDED. THE SAME SAMPLE WAS ALSO TESTED ON A CENTAUR ANALYZER AND THE FT3 RESULT WAS 2.12 PG/ML (3.25 PMOL/L). NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE FT3 REAGENT LOT NUMBER WAS 158371. THE FT4 REAGENT LOT NUMBER 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
    1 054 YR