BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2032849 · Received March 29, 2011

    Report

    Report Number
    2050012-2011-00902
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE TESTED FROM BD GREEN TOP LITHIUM HEPARIN TUBES. THE CUSTOMER INDICATED THE INSTRUMENT SHOWED CUVETTE NOT DRY ERRORS. THE CUSTOMER REPLACED THE WASH CONCENTRATE, WHICH WAS EMPTY. THE CUSTOMER DID A CUVETTE-CLEAN MAINTENANCE, CHANGED THE CUVETTE WIPER AND CHECKED THE HYDRO LINES FOR LEAKS. SERVICE VISITED ON (B)(6) 2011 AND FOUND REAGENT SYRINGE LOOSE AND LEAKING. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE 3-WAY VALVE, HAMILTON A/B VALVE AND SYRINGE AND GLASS BARREL. REPAIRS BY THE CUSTOMER AND SERVICE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW TRIGLYCERIDE (TG) AND CHOLESTEROL (CHOL) RESULTS GENERATED BY UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER. APPROXIMATELY 4 OR 5 RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THERE WAS NO IMPACT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1