BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEUMATOID FACTOR REAGENT

    MDR report key: 2464750 · Received February 22, 2012

    Report

    Report Number
    2050010-2012-00008
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    December 11, 2011
    Report Date
    December 15, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K963048
    Removal / Correction Number
    2050012-01/26/2012-003C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ONE OF TWO REPORTS RELATED TO TWO EVENTS THAT OCCURRED ON THE SAME DAY. THIS REPORT IS RELATED TO MDR#2050010-2012-0007.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE PERCENTAGE OF POSITIVE RHEUMATOID FACTOR (RF) RESULTS INCREASED AFTER USING RF REAGENT LOT M012376. CUSTOMER REPORTED THAT THE RESULTS WERE ALWAYS A LITTLE OVER 20 IU/ML. CUSTOMER REPORTED THAT THE RESULTS WERE GENERATED BY THE IMMAGE IMMUNOCHEMISTRY SYSTEM. CUSTOMER REPORTED THAT THE FALSE POSITIVE RF RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEUMATOID FACTOR REAGENT SYSTEM, TEST, RHEUMATOID FACTOR DHR BECKMAN COULTER, INC. M012376

    Patients

    Seq Age Sex Outcome Treatment
    1