BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® RHEUMATOID FACTOR REAGENT

    MDR report key: 2140004 · Received June 25, 2011

    Report

    Report Number
    2050012-2011-02623
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    February 14, 2011
    Report Date
    May 25, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE PREPARATION AND HANDLING INFORMATION ASSOCIATED WITH THIS EVENT WERE NOT SUPPLIED BY THE CUSTOMER. CALIBRATION AND QC RESULTS FAXED BY CUSTOMER APPEAR TO BE ACCEPTABLE. THE CUSTOMER HAS NOT REPORTED ANY OTHER CHEMISTRY ISSUES OR SYSTEM ERRORS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT, AS IT APPEARS TO BE REAGENT RELATED. A CUSTOMER NOTIFICATION LETTER WAS DISTRIBUTED IN ASSOCIATION WITH THIS RHEUMATOID FACTOR LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBTAINED FALSELY POSITIVE RHEUMATOID FACTOR (RF) ASSAY RESULT OF 25 IU/ML, GENERATED FROM A UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM IN ASSOCIATION WITH A SPECIFIC RHEUMATOID FACTOR (RF) REAGENT LOT. NO REPEAT OR CONFIRMATORY TESTING RESULTS WERE PROVIDED BY THE CUSTOMER. HENCE IT CANNOT BE VERIFIED THAT THE INITIAL RESULT WAS, IN FACT, ERRONEOUS. THE INITIAL, POSITIVE RESULT WAS RELEASED FROM THE LABORATORY; HOWEVER, THE CUSTOMER INDICATED THAT THEY DID NOT RECEIVE ANY REPORTS OF PATIENT TREATMENT BEING AFFECTED.

    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 M004772

    Patients

    Seq Age Sex Outcome Treatment
    1