BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2132101 · Received June 16, 2011

    Report

    Report Number
    2050012-2011-02212
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 17, 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

    BCI REVIEW OF THE CUSTOMER'S QC CHARTS SHOWS GENERAL IMPRECISION FOR NA AND CL PRIOR TO THE EVENT. THE RESULTS WERE WITHIN THE LABORATORY ESTABLISHED RANGES, HOWEVER, THE LAB'S RANGES ARE WIDE. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THAT THE RATIO PUMP WAS CRACKED AND INTRODUCING AIR INTO THE LINES. FSE REPLACED THE RATIO PUMP AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING LOW ANION GAPS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER COULD NOT STATE IF THE ISSUE WAS CAUSED BY SODIUM (NA), CHLORIDE (CL) OR CO2. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. WHEN THE ANION GAP WAS LOW, THE SAMPLES WERE REPEATED AND RESULTS WERE REPORTED OUT. THE CUSTOMER COULD NOT PROVIDE HOW MANY SAMPLES WERE AFFECTED, WHICH ANALYTE CAUSED THE ISSUE OR THE MAGNITUDE OF THE DIFFERENCE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1