BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3072770 · Received April 23, 2013

    Report

    Report Number
    1823260-2013-02468
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 20, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. THE SAMPLES WERE TESTED WITH RETENTION KITS A-TPO LOT NUMBER 168100, FT4 LOT NUMBER 170368, FT4 GENERATION 2 LOT NUMBER 169825 AND T4, LOT NUMBER 168084. THE CUSTOMER'S RESULTS WERE REPRODUCED WHEN SAMPLES WERE TESTED WITH A- TPO, FT4, AND T4. THE SAMPLE RESULTS DECREASED TO THE NORMAL RANGE WHEN TESTED WITH FT4 GENERATION 2. THE FT4 GENERATION 2 REAGENT HAS LESS INTERFERENCE AGAINST THE RUTHENIUM LABEL. BASED UPON THE RESULTS OF THIS TESTING, THE MOST LIKELY CAUSE OF THE ELEVATED RESULTS IS AN INTERFERING FACTOR TO THE RUTHENIUM LABEL IN THE PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE FREE THYROXINE (FT4), THYROTROPIN (TSH), THYROXINE (T4), AND ANTIBODIES TO THYROID PEROXIDASE (ATPO) RESULTS FOR ONE PATIENT ON THEIR E601 ANALYZER. THE CUSTOMER STATED THE PATIENT'S RESULTS DID NOT COMPARE WITH TESTING ON OTHER METHODOLOGIES OR THE CLINICAL HISTORY OF THE PATIENT. THE CUSTOMER PROVIDED DATA FOR DISCREPANT FT4 AND TSH RESULTS. THE ATPO AND T4 RESULTS WERE ALSO DISCREPANT AND NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S INITIAL FT4 RESULT WAS 34.27 PMOL/L. THE PATIENT'S INITIAL TSH RESULT WAS 0.58 UUI/ML. NEITHER DISCREPANT RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON THE E601 AND THE INITIAL RESULTS WERE CONFIRMED. ON (B)(6) 2013, THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON AN UNKNOWN ANALYZER. THE FT4 RESULT WAS 1 NG/DL. THE TSH RESULT WAS 0.57 UUI/ML. ON (B)(6) 2013, THE SAMPLE WAS SENT TO A THIRD LABORATORY AND TESTED WITH CLIA BECKMAN COULTER DEVICE. THE FT4 RESULT WAS 1.08 NG/DL. THE TSH RESULT WAS 0.94 UUI/ML. IT WAS UNKNOWN WHICH RESULTS WERE CORRECT. THE PATIENT DID NOT HAVE ANY CLINICAL SYMPTOMS AND WAS APPARENTLY NOT TAKING ANY MEDICATIONS. NO ADVERSE EVENTS WERE KNOWN AND NO CLINICAL INTERVENTION WAS PERFORMED. THE FT4 REAGENT LOT NUMBER WAS 00170368 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE TSH REAGENT LOT NUMBER WAS 00169972 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175475 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 028 YR