BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2098356 · Received May 22, 2011

    Report

    Report Number
    2050012-2011-01880
    Event Type
    Malfunction
    Date Received
    May 22, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM, NO SAMPLE ISSUES WERE NOTED, SERUM INDEXES WERE NOT RUN. FOR THE BOTH SAMPLES, THE FIRST RUN THAT WAS DONE GAVE "NO REAGENT ON SYSTEM" ERRORS FOR ALL CARTRIDGE CHEMISTRIES. CUSTOMER NOTED THAT QC IS ALSO OCCASIONALLY 0 AND WITHIN ACCEPTABLE RANGE WHEN RERUN. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED PREVENTIVE MAINTENANCE ON THE SAMPLE AND REAGENT PIPETTING SYSTEMS, WHICH HAS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO ERRONEOUS LOW TBIL AND DBIL RESULTS ON TWO PATIENTS GENERATED BY UNICEL DXC 800 PRO CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND HIGHER RESULTS WERE OBTAINED. NO AFFECT TO PATIENT TREATMENT, THE INCORRECT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY.

    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 800P N/A

    Patients

    Seq Age Sex Outcome Treatment
    1