BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3141193 · Received June 3, 2013

    Report

    Report Number
    1061932-2013-01024
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 14, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: MALS - MEDIAN ANGLE LIGHT SCATTER. LMALS - LOWER MEDIAN ANGLE LIGHT SCATTER. UMALS - UPPER MEDIAN ANGLE LIGHT SCATTER. AMTC - AIR-MIX TEMPERATURE CONTROL.

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND VERIFIED ALIGNMENTS FOR THE DXH 800 SERIAL NUMBER (B)(4). THE FSE NOTED THAT CV (COEFFICIENT OF VARIATION) ON MALS, LMALS, AND UMALS WERE TRENDING HIGH AND PROCEEDED TO TIGHTEN ALL SCREWS ON THE VC (VACUUM CHAMBER), BLEACHED THE VCSN (VOLUME, CONDUCTIVITY AND LIGHT SCATTER FOR MULTIPLE ANGLES) MODULE, REPLACED THE TUBING ON THE AMTC MODULE AND PERFORMED REALIGNMENT. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. RAW DATA WAS RECEIVED AND CONCLUSION IS PENDING COMPLETION OF ANALYSIS. EVALUATION: RAW DATA ANALYSIS. RESULTS: VCSN MODULE, AND ALIGNMENT. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 1061932-2013-01024, 1061932-2013-01025, 1061932-2013-01039.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RAW DATA PROVIDED INDICATES THAT THE ALGORITHM SET A BLAST FLAG FOR THE FIRST RUN BUT SET NO FLAG FOR THE SECOND RUN. THE RAW DATA FILE HAS BLASTS ACCORDING TO THE CUSTOMER COMMENTS BUT MANUAL REFERENCE WAS NOT PROVIDED FOR THIS EVENT. THE HISTOGRAM PATTERNS OF THE TWO RUNS LOOK SIMILAR AND SHOW SLIGHTLY ELONGATED MONOCYTE POPULATIONS ON THE FIRST RUN. THE WBC (WHITE BLOOD CELL) HISTOGRAMS SHOW RELATIVELY LOW GRANULOCYTE PEAKS. UNLIKE THE FIRST RUN, THE FLAGGING SCORE FOR THE SECOND RUN WAS SLIGHTLY LOWER THAN THE BUILT-IN CRITERIA AND THEREFORE NO FLAG WAS SET. THIS EVENT APPEARS TO BE A BORDERLINE CASE WHERE THE ALGORITHM IS NOT CONFIDENT ENOUGH TO SET FLAGS IN A CONSISTENT MANNER.

    Description of Event or Problem · 1

    DURING A CORRELATION STUDY, THE CUSTOMER REPORTED DISCOVERING FOUR (4) PATIENTS WHO HAD BLASTS ON THEIR BLOOD FILM BUT THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM DID NOT GENERATED SUSPECT MESSAGE FOR BLASTS, ON SEPARATE DAYS, INVOLVING TWO (2) UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER STATED THAT BOTH DXH 800 INSTRUMENTS ARE IN USE AT THE CUSTOMER'S LABORATORY TO REPORT PATIENT RESULTS. THE CUSTOMER STATED 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. ALTHOUGH THE CUSTOMER INITIALLY ALLEGED FOUR (4) PATIENTS WERE AFFECTED, THE CUSTOMER ONLY PROVIDED DATA FOR THREE (3) PATIENTS. THIS REPORT REFERENCES UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM SERIAL NUMBER (B)(4) ON THE EVENT DATE NOTED. DATA REVIEW OF THE PROVIDED PRINTOUTS INDICATES THAT PATIENT #1'S SAMPLE WAS RUN TWICE ON THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM SERIAL NUMBER (B)(4), AND THE INSTRUMENT GENERATED SUSPECT MO (MONOCYTES) AND NE (NEUTROPHILS) BLAST MESSAGES ON THE INITIAL RUN. HOWEVER, THE INSTRUMENT DID NOT GENERATE ANY FLAG OR SUSPECT MESSAGE ON THE RERUN OF THE SAMPLE. WBC (WHITE BLOOD CELL) AND DIFFERENTIAL RESULTS CORRELATE BETWEEN THE TWO RUNS ON THE INSTRUMENT. THE SAMPLE WAS COLLECTED IN A 4 ML EDTA (ETHYLENEDIAMINETETRAACETIC ACID) VACUTAINER TUBE AND RAN WITHIN 24 HOURS AFTER THE DRAW. ROUTINE CONTROL RUNS INDICATE THAT 6C CONTROL WAS PERFORMING WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243468 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR