BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT)

    MDR report key: 2021276 · Received March 17, 2011

    Report

    Report Number
    2050012-2011-00726
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    K971788
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT QC IS RECOVERING WITHIN THE ACCEPTABLE RANGE. NO SYSTEM ISSUES WERE NOTED BY THE CUSTOMER. THIS EVENT IS A REAGENT RELATED ISSUE. THUS, SERVICE WAS NOT NEEDED FOR THIS EVENT. A NEWER LOT OF RF REAGENT WILL BE SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSELY POSITIVE RHEUMATOID FACTOR (RF) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RETESTED WITH AN ALTERNATE CALIBRATOR THAT CONFIRMED THE SAMPLES TO YIELD NEGATIVE RF RESULTS. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT. THIS REPORTABLE EVENT CAPTURES THE RF RESULTS THAT WERE GENERATED ON (B)(6) 2011. THIS REPORT IS RELATED TO THE FOLLOWING MDRS THAT ARE BEING REPORTED ON DIFFERENT DATES FOR THE SIMILAR EVENTS THAT OCCURRED AT THIS CUSTOMER SITE: 2050012-2011-00725, 2050012-2011-00727, 2050012-2011-00763, 2050012-2011-00728, 2050012-2011-00729, 2050012-2011-00730, 2050012-2011-00731, 2050012-2011-00733, 2050012-2011-00734, 2050012-2011-00735, 2050012-2011-00737, 2050012-2011-00738.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT) RHEUMATOID FACTOR REAGENT DHR BECKMAN COULTER INC. NA M004772

    Patients

    Seq Age Sex Outcome Treatment
    1