BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 2061423 · Received April 18, 2011

    Report

    Report Number
    1823260-2011-02094
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 9, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ROOT CAUSE COULD BE DETERMINED. THE MOST LIKELY CAUSE OF THE FALSE LOW TSH VALUE AFTER DILUTION WAS EITHER AN EMPTY DILUENT BOTTLE OR BY INSUFFICIENT SAMPLE VOLUME CAUSED BY CLOT OR FIBRIN PRESENT IN THE UNDILUTED SAMPLE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY WERE GETTING QUESTIONABLE RESULTS FOR THYROTROPIN (TSH). ON (B)(6) 2011, THE CUSTOMER PERFORMED THREE TESTS ON THEIR COBAS E411 AND RECEIVED RESULTS OF 100UIU/ML ACCOMPANIED BY A DATA FLAG EACH TIME. THE ANALYZER PERFORMED A 1:10 DILUTION AND GENERATED A RESULT OF 0.312 UIU/ML WHICH WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2011, THE CUSTOMER RAN THREE TESTS WITH RESULTS OF 100 UIU/ML ACCOMPANIED BY A DATA FLAG. THE CUSTOMER RAN A FOURTH TEST AND RECEIVED 0.188 UIU/ML. THE CUSTOMER DID A MANUAL 1:2 DILUTION AND RECEIVED 141.1 UIU/ML WHICH WAS REPORTED OUTSIDE THE LABORATORY. ALL TESTS WERE PERFORMED ON THE SAME ANALYZER. THE CUSTOMER STATED THAT TREATMENT WAS WITHHELD BECAUSE OF THE LOW TEST RESULT FROM (B)(6) 2011, BUT THERE IS NO ALLEGATION OF ANY ADVERSE EVENT. THE LOT NUMBER OF THE TSH IS 16037401. THE FIELD SERVICE REPRESENTATIVE BELIEVES THE CAUSE WAS THE REAGENTS. THE TSH AND DILUENT PACKS WERE BOTH EMPTY. HE REPLACED BOTH. HE CHECKED THE LIQUID LEVEL DETECTOR AND PIPETTOR. CALIBRATION AND QUALITY CONTROL WAS PERFORMED WITH PASSING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1