BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2080302 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01395
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED. QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. QC WAS NOT RUN AFTER THE EVENT PRIOR TO RECALIBRATION. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWING: CHECKED THE FLOWCELL FOR CONTAMINATION. CLEANED THE CO2 PORT. REPLACED THE SODIUM NA ELECTRODE (PER CUSTOMER REQUEST). TIGHTENED THE MC SAMPLE SYRINGE FITTINGS. VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH CO2 RESULTS ON TWO PATIENTS GENERATED BY THE UNICEL DXC 600I SYNCHRON CHEMISTRY ANALYZER. ONE OF THE RESULT'S WAS REPORTED OUT OF THE LABORATORY; HOWEVER, IT IS UNKNOWN WHICH PATIENT RESULT WAS REPORTED OUT. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND LOWER RESULTS WERE OBTAINED AND ONE RESULT WAS AMENDED. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE REPORTED RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1