BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3092957 · Received May 3, 2013

    Report

    Report Number
    1061932-2013-00740
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIGATE THE ISSUES. THE FSE REVIEWED AND RESEARCHED PROBLEMS WITH PATIENT RESULTS. THE FSE DOWNLOADED THE RAW DATA (INF) FILES TO PRODUCT SPECIALISTS WHO REPORTED A HIGH AMOUNT OF NOISE GENERATED IN THE FLOW CELL COUNTING. WHEN AT THE CUSTOMER SITE, THE FSE REPLACED THE FLOW CELL TUBING HARNESS, AND FLOW CELL WASTE MANIFOLD WITH NO RESOLUTION. THE FSE REPLACED A SHEATH PRESSURE TANK BECAUSE THE INSTRUMENT WAS GIVING A PERIODIC "SHEATH/SAMPLE TANK NOT FULL" ERROR, BUT INDICATED THE SHEATH PRESSURE TANK WAS NOT GENERATING THE NOISE. THE FSE REPLACED FLOW CELL SAMPLE LINE PELTIER, AND MULTI TRANSDUCER MODULE (MTM) AND NOISE WAS GREATLY DECREASED. THE FSE PERFORMED MTM PHASE AND GAIN ADJUSTMENTS TO CHECK AND VERIFY FLOW CELL ALIGNMENT. THE FSE PERFORMED A START-UP, REPRODUCIBILITY AND RAN CONTROLS WITH ALL RESULTS IN RANGE AND NO NOTED PROBLEMS. THE FSE RETURNED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE REPLACED THE VOLUME, CONDUCTIVITY AND LIGHT SCATTER FOR MULTIPLE ANGLES (VCSN) PRE-AMP TO REDUCE THE NOISE INTERFERENCE FOUND WHILE INVESTIGATING THE RAW DATA FILES. THE FSE ALSO REPLACED SUSPECT PROBE BLOOD DETECTOR, PERFORMED FLOW CELL ALIGNMENT, AND CHECKED GAIN AND PHASE ADJUSTMENTS. THE FSE PERFORMED A START-UP, REPRODUCIBILITY AND RAN CONTROLS WITH ALL RESULTS IN SPECIFICATIONS AND NO NOTED ERRORS. FAILURE MODE WAS RELATED TO THE NOISE INTERFERENCE. HOWEVER, MOST SAMPLES PROVIDED INSTRUMENT GENERATED MESSAGE OR NON-NUMERIC RESULTS WHICH ALERTED THE CUSTOMER TO REVIEW THE RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONGOING DIFFERENTIAL (DIFF) ISSUES ON THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE ERRONEOUS DIFF RESULTS WERE OCCURRING INTERMITTENTLY. THE COMPLAINT STATES THE CUSTOMER HAS BEEN COLLECTING DATA FOR OVER A MONTH. HOWEVER, ACTUAL DATA PROVIDED BY THE CUSTOMER IS FROM (B)(6) 2013. A TOTAL OF TWENTY SIX (26) INSTRUMENT PRINTOUTS (COLLECTED OVER FIVE DAYS) WERE PROVIDED WHICH DEMONSTRATED ERRONEOUS DIFF AND/OR NRBC RESULTS. TWENTY TWO (22) SAMPLES INDICATE THE DIFF AND/OR NUCLEATED RED BLOOD CELL (NRBC) COUNTS WERE EITHER ERRONEOUS OR DIFF AND/OR NRBC GAVE VOTE-OUTS (NON-NUMERIC) RESULTS. THE DIFF AND NRBC RESULTS WERE PRINTED WITH THE INSTRUMENT GENERATED MESSAGES EXCEPT FOR FOUR (4) OF THE SAMPLES, WHERE NO INSTRUMENT GENERATED MESSAGES WERE PROVIDED. MANUAL DIFFERENTIAL RESULTS WERE ONLY PROVIDED FOR THREE SAMPLES; IT IS UNKNOWN IF MANUAL SMEARS WERE PERFORMED FOR THE REMAINING SPECIMENS. CONTROLS WERE RUN BEFORE THE INCIDENT AND RECOVERED WITHIN RANGE. PREVIOUSLY-RUN PATIENT SAMPLES WERE RERUN TO CONFIRM ACCURATE BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. THIS REPORT DOCUMENTS PATIENT RESULTS GENERATED ON (B)(6) 2013. THE CUSTOMER INDICATED THAT THEY HAD REPORTED ERRONEOUS DIFFERENTIAL RESULTS OUT OF THE LABORATORY ON ONE PATIENT. THE LABORATORY TECHNICIAN QUESTIONED THE RESULTS, PERFORMED A MANUAL DIFFERENTIAL, AND CALLED THE DOCTOR WITH THE CORRECT RESULT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT. MDRS ASSOCIATED WITH DIFF AND NRBC RESULTS GENERATED BY THE DXH INSTRUMENT AT THIS CUSTOMER SITE: 1061932-2013-740, 1061932-2013-741, 1061932-2013-742, 1061932-2013-743, 1061932-2013-744.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195212 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR