BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1970587 · Received January 25, 2011

    Report

    Report Number
    2050012-2011-00241
    Date Received
    January 25, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QC WAS WITHIN LAB'S ESTABLISHED RANGES PRIOR TO AND POST THE EVENT. ON (B)(4) 2010, A BCI FIELD SERVICE ENGINEER (FSE) FOUND PRECIPITANT IN THE CL PORT OF FLOW-CELL. FSE CLEANED AND REPLACED THE CL ELECTRODE. FSE REPLACED VALVES AND FLUSHED LINE ON THE VACUUM TO THE ELECTROLYTE INJECTION CUP (EIC). FSE VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH SODIUM (NA), CHLORIDE (CL), POTASSIUM (K), AND CARBON DIOXIDE (CO2) RESULTS ON TWO PATIENTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE UNIT AND LOWER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE ERRONEOUS HIGH RESULT REPORTED.

    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