BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEUMATOID FACTOR TEST SYSTEM

    MDR report key: 2159655 · Received July 12, 2011

    Report

    Report Number
    2050012-2011-02895
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    K042291
    Removal / Correction Number
    2050012-06/24/2011-024R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED. ON (B)(6) 2011 USING REAGENT LOT M010568 AND CALIBRATOR LOT M911470, THE RF CALIBRATION FAILED, MATH ERROR ON (B)(6) 2011 USING REAGENT LOT M010568 AND CALIBRATOR LOT M003575, THE RF CALIBRATION FAILED, MATH ERROR ON (B)(6) 2011 USING REAGENT LOT M010568 AND CALIBRATOR LOT M003575, THE RF CALIBRATION PASSED. A REVIEW OF QC (B)(4) CHARTS FROM (B)(6) 2011 SHOWS SHIFTS OF 3 SD'S BOTH HIGH TO LOW AND LOW TO HIGH. RF SAMPLES ARE BEING SENT TO ANOTHER LABORATORY FOR TESTING SERVICE WAS NOT REQUESTED. A CUSTOMER NOTIFICATION LETTER HAS BEEN DISTRIBUTED IN ASSOCIATION WITH THIS RHEUMATOID FACTOR LOT. 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 RHEUMATOID FACTORS (RF) RESULTS >20 IU/ML HAVE BEEN GENERATED ON 33% OF PATIENT SAMPLES USING WHEN USING MULTIPLE LOTS OF REAGENT AND CALIBRATOR. THE DATE OF THE SAMPLE RANGE FROM (B)(6) 2011. THE CAUSE HAS BEEN IDENTIFIED AS REAGENT RELATED. . A 20 SAMPLE COMPARISON RUN WAS DONE ON (B)(6) 2011. THE SAME 20 SAMPLES WERE COMPARED TO TWO OTHER METHODS, ONE LABELED (B)(4) AND THE OTHER LABELED (B)(4). THE RESULTS ARE ATTACHED. NO INDICATION THAT PATIENT TREATMENT WAS ADVERSELY AFFECTED BASED ON THE ELEVATED RF RESULTS.

    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 M007324

    Patients

    Seq Age Sex Outcome Treatment
    1