BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 867938 · Received June 19, 2007

    Report

    Report Number
    2050012-2007-00014
    Event Type
    Other
    Date Received
    June 19, 2007
    Date of Event
    May 23, 2007
    Report Date
    June 19, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RUNS QC ONCE A DAY. BASED ON DATA PROVIDED, NO QC PROBLEMS WERE NOTED. THE OBSTRUCTION DETECTOR (ODC) WAS ENABLED AT THE TIME OF THIS EVENT. PER CUSTOMER, NO INSTRUMENT PROBLEMS WERE RECORDED. THE ORIGINAL SAMPLES WERE COLLECTED IN A GREY TOP PLASMA TUBE AND RED TOP SERUM TUBE. NO VISIBLE ISSUES WITH THE SAMPLE WERE NOTED BY THE CUSTOMER. THE SPECIMENS WERE CENTRIFUGED AT 3,000 RPM FOR 5 MINUTES. THE SAMPLING WAS PERFORMED WITH A NESTING, 0.5ML CUP. NO ADDITIONAL INFORMATION REGARDING THIS EVENT WAS PROVIDED. THE ROOT CAUSE OF THE EVENT IS UNKNOWN AND UNKNOWABLE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING A FALSELY LOW ETHYL ALCOHOL (ETOH) RESULT THAT WAS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. THE CUSTOMER INDICATED THAT PLASMA SAMPLE FROM A "VISIBLY INTOXICATED" ER PATIENT WAS TESTED FOR ETOH AND A SUPPRESSED RESULT OF "ORR LO" WAS OBTAINED. THE ETOH RESULT WAS BELOW THE ANALYTICAL RANGE FOR THIS ANALYTE (1.1MMOL/L), AND WAS REPORTED OUT OF THE LAB AS "<1.0 MMOL/L". APPROXIMATELY AN HOUR LATER, A FRESH SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED FOR ETOH AND A RESULT OF 123.1MMOL/L WAS GENERATED. THE CUSTOMER THEN RE-TESTED THE ORIGINAL SAMPLE FOR ETOH AND THE REPEATED RESULTS WERE: 43.1MMOL/L AND 127.9MMOL/L. A SERUM SAMPLE COLLECTED AT THE SAME TIME AS THE ORIGINAL PLASMA SAMPLE WAS TESTED FOR ETOH AND A RESULT OF 126.0MMOL/L WAS OBTAINED. IN ADDITION, THE CUSTOMER PERFORMED A GAS CHROMATOGRAPHY (GC) FOR ETOH AND A RESULT YIELDED ">120MMOL/L". BASED ON AVAILABLE INFORMATION, PATIENT TREATMENT WAS INITIATED FOLLOWING THE SUPPRESSED ETOH RESULT WAS REPORTED. PER CUSTOMER, THE PATIENT RECORD WAS AMENDED AFTER HIGHER RESULTS WERE OBTAINED. NO OTHER ADDITIONAL PATIENT INFORMATION IS AVAILABLE AT THIS TIME.

    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 YR Other