BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT

    MDR report key: 2140127 · Received June 25, 2011

    Report

    Report Number
    2050012-2011-02596
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 27, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.THE MDRS ASSOCIATED WITH THIS EVENT ARE:2050012-2011-02582.2050012-2011-02583.2050012-2011-02584.2050012-2011-02585.2050012-2011-02586.2050012-2011-02587.2050012-2011-02588.2050012-2011-02589.2050012-2011-02609.2050012-2011-02590.2050012-2011-02591.2050012-2011-02608.2050012-2011-02592.2050012-2011-02593.2050012-2011-02594.2050012-2011-02595.2050012-2011-02596.2050012-2011-02597.2050012-2011-02598.2050012-2011-02599.2050012-2011-02612.2050012-2011-02600.2050012-2011-02601.2050012-2011-02602.2050012-2011-02603.2050012-2011-02613.2050012-2011-02604.2050012-2011-02614.2050012-2011-02605.2050012-2011-02606.2050012-2011-02626. (B)(4).

    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 600I SYNCHRON ACCESS CLINICAL SYSTEM IN ASSOCIATION WITH A SPECIFIC SYNCHRON SYSTEM RHEUMATOID FACTOR (RF) REAGENT LOT. THIS WAS A MULTI-DAY EVENT. THIS REPORT IS SEVENTEEN 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 THE CUSTOMER STATED THAT THEY DID NOT BELIEVE THAT ANY MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. ADDITIONALLY THERE HAVE BEEN NO REPORTS OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE EVENT BEGAN WITH THE USAGE OF A NEW SYNCHRON SYSTEM RHEUMATOID FACTOR (RF) REAGENT LOT (M010568). THE CUSTOMER REPORTED THAT THE INSTRUMENT QUALITY CONTROL MEAN RESULTS DISPLAYED A DOWNWARD SHIFT UPON THE INITIATION OF RF REAGENT LOT M010568. SYSTEM CALIBRATION RESULTS ASSOCIATED WITH THIS REAGENT LOT APPEARED TO MEET ESTABLISHED SPECIFICATION. THE CUSTOMER HAS NOT REPORTED ANY OTHER CHEMISTRY ISSUES OR SYSTEM ERRORS. SAMPLE PREPARATION AND HANDLING INFORMATION ASSOCIATED WITH THIS EVENT WERE NOT SUPPLIED BY THE CUSTOMER. CUSTOMER SUPPLIED DATA INDICATED FOUR 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 600I SYNCHRON ACCESS CLINICAL SYSTEM