BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1961773 · Received January 14, 2011

    Report

    Report Number
    2050012-2011-00160
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT QC HAS BEEN WITHIN RANGE. NO SPECIFIC SYSTEM ISSUES WERE NOTED. SERVICE WAS NOT NEEDED FOR THIS EVENT, AS THIS IS A REAGENT ISSUE. THE BCI HOTLINE RECOMMENDED THE CUSTOMER TO RERUN PATIENT SAMPLES USING A NEW REAGENT LOT. INVESTIGATION INTO THE ROOT CAUSE OF THIS ISSUE IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSELY POSITIVE RHEUMATOID FACTOR (RF) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER PROVIDED A LONG LIST OF PATIENT RESULTS BETWEEN 20.0 AND 30.0 IU/ML WITHOUT ANY CONFIRMATORY DATA TO INDICATE WHICH RESULTS WERE DISCREPANT. PATIENT TREATMENT HAS NOT BEEN IMPACTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1