BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3171362 · Received June 14, 2013

    Report

    Report Number
    1061932-2013-01053
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED BECKMAN COULTER WITH RAW DATA FILES OF THE EVENT AND ANALYSIS INDICATES THE PRESENCE OF BLASTS (11%) AND VARIANT LYMPHOCYTES (% NOT AVAILABLE) ACCORDING TO THE MANUAL SLIDE REVIEW. THE ALGORITHM SET NO SUSPECT FLAGS AND THE HISTOGRAMS SHOW ABNORMALLY ELONGATED LYMPHOCYTE POPULATIONS, BUT THE ABNORMALITY OF THE POPULATION WAS NOT ENOUGH FOR THE ALGORITHM TO SET BLAST OR VARIANT LYMPHOCYTE FLAGS. FAILURE MODE, AS PER RAW DATA ANALYSIS, IS THAT THE ABNORMALITY OF THE POPULATION WAS NOT ENOUGH FOR THE ALGORITHM TO SET BLAST OR VARIANT LYMPHOCYTE FLAGS. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 1061932-2013-01053, 1061932-2013-01054.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TWO (2) UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM FAILED TO FLAG FOR BLAST AND VARIANT LYMPHOCYTES, WHILE IN AUTOMATED DIFFERENTIAL MODE, WHICH WERE DISCOVERED BY THE LABORATORY ON A MANUAL SLIDE REVIEW ON A PARTICULAR SAMPLE. THE CUSTOMER INDICATED THAT THE ALLEGED ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND A CORRECTED REPORT WAS ISSUED AFTER THE LABORATORY PERFORMED A MANUAL SLIDE REVIEW AND FOUND THE PRESENCE OF BLASTS AND VARIANT LYMPHOCYTES. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THIS REPORT REFERENCES THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM SERIAL NUMBER (B)(4) ON THE EVENT DATE NOTED. A REVIEW OF THE PROVIDED DATA INDICATES THAT THE AUTOMATED DIFFERENTIAL GAVE LOW NE (NEUTROPHILS) AND HIGH LY (LYMPHOCYTES) WITHOUT ANY INSTRUMENT GENERATED MESSAGES ON EACH OF THE DXH 800 INSTRUMENT. MANUAL DIFFERENTIAL SHOWS THE PRESENCE OF 11% BLASTS IN THE SAMPLE BUT DOES NOT SHOW THE PRESENCE OF VARIANT LYMPHOCYTES. THE SAMPLE WAS COLLECTED IN A 4 ML EDTA LAVENDER TOP VIAL AND APPEARED NORMAL. THE SAMPLE WAS RUN WITHIN ONE HOUR AFTER IT HAD BEEN STORED AT ROOM TEMPERATURE. THE CUSTOMER STATED THAT THE OCCURRENCE OF THE EVENT WAS RELATED TO ONE SAMPLE ONLY. QC (QUALITY CONTROL) PERFORMED WITHIN SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND RECOVERED RESULTS WITHIN ASSAY RANGES ON BOTH INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271137 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR