BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1669285 · Received April 28, 2010

    Report

    Report Number
    2050012-2010-00225
    Event Type
    Malfunction
    Date Received
    April 28, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 28, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE DRAWN IN GREINER PLASMA TUBES. THE SAMPLES WERE POURED OF ALIQUOTS RECEIVED FROM THE PHYSICIAN'S OFFICE. THE SYSTEM IS ROUTINELY CALIBRATED EVERY 24 HOURS AND QC SAMPLES ARE RUN EVERY 8 HOURS. QC RESULTS BEFORE AND AFTER EACH EVENT WERE WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) CONFIRMED THE SYSTEM IS RUNNING WITHIN SPECIFICATIONS. ALTHOUGH THE CUSTOMER BELIEVES THE PROBLEM IS WITH SAMPLES RECEIVED IN ALIQUOT TUBES FROM THE PHYSICIAN'S OFFICE, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. 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) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ORIGINAL RESULT OBTAINED FOR PATIENT #1 WAS 113 MMOL/L. UPON REPEAT ON THE SAME INSTRUMENT THE RESULT OBTAINED WAS 116 MMOL/L WHICH WAS REPORTED OUTSIDE OF THE LAB. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED ON A DIFFERENT INSTRUMENT. A HIGHER RESULT WAS OBTAINED AND THE REPORT WAS AMENDED. THE ORIGINAL RESULT OBTAINED FOR PATIENT #2 WAS 119 MMOL/L. UPON REPEAT ON THE SAME INSTRUMENT THE RESULT OBTAINED WAS 100 MMOL/L. UPON REPEAT ON A DIFFERENT INSTRUMENT THE RESULT OBTAINED WAS 100 MMOL/L. FOR PATIENT #1 THE REPORTED RESULT WAS NOT BELIEVED AND THERE WAS NO CHANGE IN TREATMENT MANAGEMENT. PATIENT #2 WAS SENT TO ANOTHER FACILITY'S EMERGENCY ROOM WHERE THE PATIENT WAS REDRAWN AND FOUND TO HAVE A VALUE WITHIN REFERENCE RANGE. THERE WAS NO OTHER CHANGE TO TREATMENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1