BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2870408 · Received December 12, 2012

    Report

    Report Number
    1061932-2012-02823
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE FRONT OF THE WHITE BLOOD CELL (WBC) HISTOGRAM SHOWS A MODERATE INTERFERENCE PATTERN. THE NUCLEATED RED BLOOD CELL (NRBC) SCATTER PLOT HAS SOME DEBRIS EVENTS, BUT NOT ENOUGH TO TRIGGER THE PLATELET CLUMP FLAG. AS A RESULT, THE ALGORITHM DID NOT FLAG FOR CLUMPS. THERE WAS NOT SIGNIFICANT INTERFERENCE OF DEBRIS NOTED ON WBC HISTOGRAM OR NRBC MODULE (FOR PLATELET EVENTS). THE CUSTOMER ALSO PERFORMED A MANUAL WBC CORRECTION USING THE OBSERVED PLATELET (PLT) CLUMPS ON THE SLIDE. A REVIEW OF THE WBC HISTOGRAM DID NOT INDICATE A SIGNIFICANT AMOUNT OF THE DEBRIS. IN ADDITION, THE NRBC MODULE HAS ONLY APPROXIMATELY 4% OF PLATELET CLUMPS. THEREFORE, THE MANUAL CORRECTION ON THE WBC MAY NOT HAVE BEEN NEEDED.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT EVALUATED. THE CUSTOMER FORWARDED A PRINTOUT OF THE RESULTS FROM THE SYSTEM FOR THIS EVENT. THE PRINTOUT WAS REVIEWED; HOWEVER, NO CONCLUSION CAN BE DRAWN FROM THE INFORMATION PROVIDED. PER LABELING: GIANT PLATELETS, PLATELET CLUMPS, WHITE CELL FRAGMENTS, ELECTRONIC NOISE, VERY SMALL RED CELLS, AND RED CELL FRAGMENTS ARE LISTED AS INTERFERING SUBSTANCES FOR PLATELET PARAMETER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT ERRONEOUS LOW PLATELET (PLT) RESULTS WERE GENERATED BY THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM WITHOUT INSTRUMENT GENERATED FLAGS, FOR A PATIENT SPECIMEN CONTAINING PLATELET CLUMPS. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THE LOW PLATELET VALUE PROMPTED THE CUSTOMER TO PERFORM A MANUAL REVIEW WHERE THE PLATELET CLUMPS WERE DETECTED (115 PLT CLUMPS/100 WHITE BLOOD CELLS (WBC). THE WBC RESULT WAS THEN CORRECTED FROM 14.5 TO 6.7. ACCORDINGLY, THE WBC RESULT WAS CONSIDERED ERRONEOUSLY HIGH, WITH NO INSTRUMENT FLAGS. ADDITIONALLY, AN ACCURATE MANUAL PLATELET COUNT COULD NOT BE OBTAINED DUE TO THE PLATELET CLUMPING. THERE ARE NO REPORTS OF ADVERSE EVENTS OR THE NEED FOR ANY MEDICAL INTERVENTION TO PREVENT AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR