BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT

    MDR report key: 2143757 · Received June 29, 2011

    Report

    Report Number
    2050012-2011-02704
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K971788
    Removal / Correction Number
    2050012-06/24/2011-024C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED FOR THIS EVENT. THE TECHNICIAN VERIFIED UNICEL DXC 800 SYNCHRON SYSTEM INSTRUMENT PERFORMANCE. CALIBRATION WAS PERFORMED AND PATIENT SAMPLES WERE RERUN WITH FRESH CALIBRATOR AND REAGENT HOWEVER RF PERFORMANCE DID NOT IMPROVED. THIS EVENT APPEARS TO BE REAGENT RELATED. A CUSTOMER NOTIFICATION LETTER WAS DISTRIBUTED IN ASSOCIATION WITH THIS RHEUMATOID FACTOR REAGENT LOT. THE MDRS ASSOCIATED WITH THIS EVENT ARE: 2050012-2011-02749, 2050012-2011-02690, 2050012-2011-02691, 2050012-2011-02692, 2050012-2011-02693, 2050012-2011-02694, 2050012-2011-02695, 2050012-2011-02696, 2050012-2011-02698, 2050012-2011-02700, 2050012-2011-02701, 2050012-2011-02702, 2050012-2011-02703, 2050012-2011-02704, 2050012-2011-02705, 2050012-2011-02706, 2050012-2011-02707, 2050012-2011-02708, 2050012-2011-02709, 2050012-2011-02710, 2050012-2011-02711, 2050012-2011-02712, 2050012-2011-02713, 2050012-2011-02714, 2050012-2011-02715, 2050012-2011-02716, 2050012-2011-02717, 2050012-2011-02718, 2050012-2011-02719, 2050012-2011-02720, 2050012-2011-02721.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBTAINED MULTIPLE, ERRONEOUS FALSE POSITIVE RHEUMATOID FACTOR (RF) ASSAY RESULTS GENERATED FROM A UNICEL DXC 800 SYNCHRON SYSTEM IN ASSOCIATION WITH A SPECIFIC SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT LOT. THIS WAS A MULTI-DAY EVENT. THIS REPORT IS FOURTEEN OF THIRTY ONE, AND REPRESENTS THE ALLEGED FALSE POSITIVE RHEUMATOID FACTOR (RF) ASSAY RESULTS GENERATED ON (B)(6) 2011. NO REPEAT, CONFIRMATORY TESTING RESULTS WERE PROVIDED BY THE CUSTOMER. HENCE IT CANNOT BE VERIFIED THAT THE INITIAL RESULTS WERE, IN FACT, ERRONEOUS. THE INITIAL, POSITIVE RESULTS WERE RELEASED FROM THE LABORATORY, HOWEVER, PHYSICIANS QUESTIONED THE RESULTS. THERE WAS NO MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THIS EVENT IS ASSOCIATED WITH A SPECIFIC SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT LOT (M010568) CUSTOMER REPORTED THAT INSTRUMENT QUALITY CONTROL RESULTS AND SYSTEM CALIBRATION RESULTS MET ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THIS EVENT THE CUSTOMER HAS NOT REPORTED ANY OTHER CHEMISTRY ISSUES OR SYSTEM ERRORS. SAMPLE PREPARATION AND HANDLING INFORMATION ASSOCIATED WITH THIS EVENT WAS NOT SUPPLIED BY THE CUSTOMER. CUSTOMER SUPPLIED DATA INDICATED SIXTEEN PATIENT SAMPLES WITH POSITIVE (GREATER THAN 20 IU/ML) RF RESULTS ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT SYSTEM, TEST, RHEUMATOID FACTOR DHR BECKMAN COULTER, INC. NA M010568

    Patients

    Seq Age Sex Outcome Treatment
    1 UNICEL DXC 800 SYNCHRON SYSTEM