BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3191900 · Received June 27, 2013

    Report

    Report Number
    1061932-2013-01204
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BECKMAN COULTER
    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: BECKMAN COULTER RECEIVED RAW DATA FILES FOR A TOTAL OF SEVEN (7) WHOLE BLOOD SAMPLES ALONG WITH THE QUALITY CONTROL (QC) DATA. THE 6C AND LATRON CONTROL RUNS SHOWED NO ALGORITHM ISSUES. ANALYSIS OF THE WHOLE BLOOD RAW DATA DID NOT SHOW ANY ALGORITHM ISSUES EITHER. SOME SAMPLES EXHIBITED HIGH MONOCYTE PERCENT VALUES BUT THE ALGORITHM CORRECTLY SEPARATED THE POPULATION. IN TWO OF THE SAMPLES, A LARGE OVERLAP BETWEEN THE MONOCYTE AND NEUTROPHIL POPULATION IS OBSERVED AND MOST LIKELY CAUSED BY THE PRESENCE OF VERY IMMATURE CELLS; THE ALGORITHM SET SUSPECT MESSAGES FOR BOTH SAMPLES.

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED ON (B)(4) 2013 AND DISCOVERED A LOW DIFFERENTIAL CELL COUNT FOR THE RECENT PATIENT RUNS. THE FSE PROCEEDED TO REPLACE AND PRIME THE DIFFERENTIAL PRESERVATIVE PUMP, PERFORM MTM (MULTI TRANSDUCER MODULE) INTEGRATED GAIN AND PHASE ADJUSTMENTS, AND CALIBRATED THE NRBC (NUCLEATED RED BLOOD CELL) WHOLE BLOOD. THE FSE VERIFIED INSTRUMENT OPERATIONS AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE OF THE EVENT IS LIKELY ATTRIBUTED TO THE DIFFERENTIAL PRESERVATIVE PUMP. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 1061932-2013-01204, 1061932-2013-01283.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING INTERMITTENT ERRONEOUSLY HIGH BASOPHILS AND/OR MONOCYTES INVOLVING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER INDICATED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER PROVIDED ONLY ONE EXAMPLE OF ERRONEOUS PATIENT RESULTS WITH THE ALLEGED ORIGINAL ERRONEOUS PATIENT RESULTS SHOWING HIGH MONOCYTE (MO%) AND LOW NEUTROPHIL (NE%) RESULTS WHEN COMPARED TO RERUN RESULTS FROM AN ALTERNATE DXH 800 INSTRUMENT. THE CUSTOMER CONSIDERS THE RERUN RESULTS TO BE CORRECT. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2013; PLEASE SEE MEDWATCH REPORT #1061932-2013-01283 FOR THE REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292830 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR