BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® RHEUMATOID FACTOR REAGENT

    MDR report key: 2103244 · Received May 25, 2011

    Report

    Report Number
    2050012-2011-01931
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K971788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CALIBRATION, QC, OR SYSTEM ISSUES WERE NOTED. THE CUSTOMER CHANGED REAGENT CARTRIDGE OF THE SAME LOT AND STILL OBTAINED SLIGHTLY POSITIVE RESULTS. THE CUSTOMER WAS PROVIDED WITH RF REAGENT LOT M010568 TO EVALUATE. SERVICE WAS NOT DISPATCHED AS THIS IS A REAGENT ISSUE. ROOT CAUSE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO FALSE POSITIVE RHEUMATOID FACTOR (RF) RESULTS GENERATED BY UNICEL DXC 860I SYNCHRON CLINICAL SYSTEM USING SYNCHRON LX RHEUMATOID FACTOR REAGENT. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE RESULTS WERE CLOSE TO THE CUT-OFF VALUE ON BCI LABELING, 20 IU/ML, AND WERE INCONSISTENT WITH THE PATIENTS' HISTORY. THERE WAS NO IMPACT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® RHEUMATOID FACTOR REAGENT RHEUMATOID FACTOR IMMUNOLOGICAL TEST DHR BECKMAN COULTER, INC. NA M009630

    Patients

    Seq Age Sex Outcome Treatment
    1