BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEUMATOID FACTOR TEST SYSTEM

    MDR report key: 2160846 · Received July 13, 2011

    Report

    Report Number
    2050012-2011-02896
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    K971788
    Removal / Correction Number
    2050012-06/24/2011-024R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED. ON (B)(6) 2011, THE CUSTOMER HAD NOTICED THAT ALL QC RESULTS USING RF REAGENT LOT (B)(4) WERE ABOVE THE ESTABLISHED MEAN. A NORMAL PATIENT STUDY WAS DONE. ALL OF THE RESULTS ON SAMPLES FROM NORMAL PATIENTS WERE >20.0 IU/ML. THE CUSTOMER HAS DISCONTINUED RUNNING SAMPLES FOR RF ON THIS ANALYZER. SERVICE WAS NOT REQUESTED. THE CAUSE HAS BEEN IDENTIFIED AS REAGENT RELATED. THIS IS A REAGENT ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT RECEIVING HIGH RHEUMATOID FACTORS (RF) RESULTS >20 IU/ML GENERATED BY THE UNICEL DXC800P DURING A NORMAL PATIENT STUDY. THE RF REFERENCE CUTOFF IS 20 IU/ML. IT IS EXPECTED THAT 95% OF PATIENT RESULTS WILL BE <20 IU/ML. ON (B)(6) 2011, RF REAGENT LOT M010568 WAS LOADED FOR THE FIRST TIME ON THE DXC800 ANALYZER. THE FIRST TWO ATTEMPTS TO CALIBRATE THE UNIT FAILED DUE TO CALCULATION/MATH ERROR. THE THIRD ATTEMPT TO CALIBRATE PASSED; HENCE PATIENT SAMPLES WERE RUN. IMMUNO QC LOT 52373 SHIFTED HIGH WHEN REAGENT LOW (B)(4) WAS LOADED. ON (B)(6) 2011, THE CUSTOMER NOTED ALL QC RESULTS USING THE RF REAGENT LOT (B)(4) WERE ABOVE THE ESTABLISHED MEAN. A NORMAL PATIENT STUDY WAS PERFORMED AND ALL OF THE RESULTS ON SAMPLES FROM NORMAL PATIENTS WERE >20.0 IU/ML. THE STUDY RESULTS ARE PROVIDED. NO ERRONEOUS RESULTS WERE SUBMITTED OUT OF THE LABORATORY. THE HIGH RF RESULTS WERE FROM A NORMAL PATIENT STUDY, HENCE NO PATIENT TREATMENT WAS IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEUMATOID FACTOR TEST SYSTEM RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM DHR BECKMAN COULTER INC. RHEUMATOID FACTORS M010568

    Patients

    Seq Age Sex Outcome Treatment
    1