BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1913230 · Received December 2, 2010

    Report

    Report Number
    2050012-2010-01479
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS ACCEPTABLE BEFORE THE EVENT, BUT QC ON CR-S HIGH CONTROL WAS A LITTLE LOW IN THE RANGE AFTER THE EVENT. A BCI CUSTOMER TECHNICAL SUPPORT (CTS) RECOMMENDED THE CUSTOMER TO USE PERSONAL PROTECTIVE EQUIPMENT (PPE) BEFORE TROUBLESHOOTING. THE CTS INSTRUCTED THE CUSTOMER TO FLUSH THE SAMPLE PROBE USING 10% WASH SOLUTION AND RINSE WITH DI WATER. THE CUSTOMER RERAN QC, AND ALL RESULTS WERE IN THE ESTABLISHED RANGES. THE CUSTOMER RAN THREE PATIENT SAMPLES ON BOTH INSTRUMENTS AND THE GLU, TBIL, CR-S, TG, AND UREA RESULTS MATCHED. THE CUSTOMER BELIEVES THE INSTRUMENT IS NOW WORKING CORRECTLY, BUT WILL CONTINUE MONITORING. AS OF (B)(4) 2010, THERE WERE NO FURTHER CALLS FOR THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS MULTIPLE CHEMISTRY RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER FOR TWO PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THAT THERE WAS NO EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1