BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1906143 · Received November 23, 2010

    Report

    Report Number
    2050012-2010-01381
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS ICTERIC AND IN A LITHIUM HEPARIN PLASMA TUBE WITH GEL SEPARATOR. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. OTHER ANALYTES WERE ELEVATED FOR THESE SAMPLES BUT WERE NOT QUESTIONED BY THE PHYSICIAN. THE TRUE GLUCOSE VALUE FOR THE PATIENT IS UNKNOWN. NO SERVICE CALL WAS GENERATED OR INITIATED. THE CUSTOMER DETERMINED THAT THE EVENT WAS SAMPLE SPECIFIC. THE SAMPLE ABSORBANCE PLOT WAS REVIEWED BY BCI. THE PLOT IS NOT TYPICAL OF A SPECTRAL INTERFERENCE BUT MORE LIKELY A CHEMICAL INTERFERENCE. THE SAMPLE IS NOT AVAILABLE FOR FURTHER INVESTIGATION BY BCI, AND THEREFORE, FURTHER INVESTIGATION OF A ROOT CAUSE IS NOT POSSIBLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO LOW GLUCOSE (GLU) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM THAT WERE DISCREPANT FROM OTHER METHODOLOGY. THE RESULTS WERE SUPPRESSED WITH OIR LO (OUT OF INSTRUMENT RANGE LOW) FLAG. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTS BY ALTERNATE METHODOLOGIES ON REDRAWN SAMPLES PRODUCED HIGHER RESULTS. THE RESULTS ARE SHOWN. THE PHYSICIAN WAS NOTIFIED OF RESULTS DURING THE PROCESSING TIME AND THE PHYSICIAN ORDERED THE TESTS BY ALTERNATE METHODOLOGIES. THE CUSTOMER IS UNAWARE OF ANY ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER CGA BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR