BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 1081626 · Received July 16, 2008

    Report

    Report Number
    2050012-2008-00027
    Event Type
    Other
    Date Received
    July 16, 2008
    Date of Event
    June 21, 2008
    Report Date
    July 16, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2008, THE AUTOMATED WEEKLY MAINTENANCE PROCEDURE WAS PERFORMED ON THE ION SELECTIVE ELECTRODE (ISE) SYSTEM. THE ISE SYSTEM WAS CALIBRATED AND QC RECOVERED WITHIN THE LAB'S ESTABLISHED RANGES. AT SOME POINT DURING THE ROUTINE OPERATION, THE OPERATOR NOTED THAT THERE WERE FREQUENT DELTA CHECK MESSAGES. QC WAS RUN AND NA QC RECOVERED UP TO 10MMOL/L LOWER THAN THE PREVIOUS RUN. ALL SAMPLES WERE THEN REPEATED ON THE LAB'S SECOND ANALYZER. THE NA RESULTS WERE SIGNIFICANTLY HIGHER AND AMENDED REPORTS WERE ISSUED. THE ISE SYSTEM ON THIS ANALYZER WAS RECALIBRATED: QC WAS WITHIN THE ESTABLISHED RANGES AND NORMAL OPERATION CONTINUED. A FIELD SERVICE ENGINEER (FSE) WORKED WITH THE CUSTOMER BY PHONE AND TOLD THE CUSTOMER THAT A LETTER WILL BE MAILED FROM BCI TO ALL DXC CUSTOMERS REGARDING ISE MAINTENANCE PROCEDURE. UNTIL THEN, THE CUSTOMER WILL PERFORM MORE FREQUENT QC RUNS AND CALIBRATE THE ISE SYSTEM AS NECESSARY. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW SODIUM (NA) TEST RESULTS PRODUCED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER FOR SEVERAL PTS. ONLY ONE EXAMPLE OF THE ERRONEOUS RESULTS WAS PROVIDED. THE ORIGINAL RESULT WAS 119 MMOL/L AND THE CORRECTED RESULT WAS 130 MMOL/L. A HOSPITAL CRITICAL EVENT REPORT WAS FILED BECAUSE A PT WAS TREATED BASED ON AN ERRONEOUS NA RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA