BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEUMATOID FACTOR REAGENT

    MDR report key: 2451813 · Received February 14, 2012

    Report

    Report Number
    2050010-2012-00004
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K963048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ERRONEOUS RHEUMATOID FACTOR RESULTS WERE GENERATED ON FOUR DIFFERENT DAYS. THIS REPORT IS ONE OF FOUR REPORTS RELATED TO FOUR EVENTS THAT OCCURRED ON FOUR DIFFERENT DAYS. THIS REPORT IS RELATED TO MDR#2050010-2012-00001, 2050010-2012-00002, 2050010-2012-00003.

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT FALSE POSITIVE RHEUMATOID FACTOR (RF) PATIENT RESULTS WERE GENERATED WHEN RHEUMATOID FACTOR REAGENT LOT NUMBER M008778 WAS USED ON THE IMMAGE IMMUNOCHEMISTRY SYSTEM. CUSTOMER REPORTED THAT NEGATIVE RESULTS WERE OBTAINED WHEN THE TESTS WERE RE-RUN WITH A DIFFERENT LOT OF RF REAGENT . CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CORRECT AN ERROR IN THE ORIGINAL REPORT. CORRECTION: THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEUMATOID FACTOR REAGENT SYSTEM, TEST, RHEUMATOID FACTOR DHR BECKMAN COULTER, INC. M008778

    Patients

    Seq Age Sex Outcome Treatment
    1