BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1883597 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01059
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 26, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE CO2 ALKALINE BUFFER TUBING, CLEANED THE FLOW CELL, THE ELECTRICAL CONNECTION (EIC), AND DAMPER. THE FSE ALSO REPLACED THE CO2 MEASURING ELECTRODE AND THE MEMBRANE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY HIGH CARBON DIOXIDE (CO2) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. SAMPLES WERE REPEATED, PRODUCING LOWER RESULTS, AND AMENDED REPORTS WERE ISSUED. THE CUSTOMER STATED THAT NO PATIENT TREATMENT WAS AFFECTED BASED ON THE HIGH CO2 RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1