BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 2416428 · Received January 15, 2012

    Report

    Report Number
    1061932-2012-00155
    Event Type
    Malfunction
    Date Received
    January 15, 2012
    Date of Event
    October 22, 2011
    Report Date
    December 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT COULD NOT BE DETERMINED BASED ON INFORMATION PROVIDED. SERVICE NOT DISPATCHED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DXH 800 GENERATED ERRONEOUS HIGH MCV AS COMPARED TO RE-RUN ON THE LH 500 ON A VARIETY OF PATIENT SAMPLES. CALCULATED PARAMETERS USING MCV AS A FACTOR [HCT, MCH, MCHC] ARE ALSO IMPACTED. THE INSTRUMENT DID NOT GENERATED FLAGS FOR 4 OF THE 5 PATIENT SAMPLES. THE CUSTOMER QUESTIONED THE RESULTS DUE TO DELTA FAILURES WHEN INITIAL AND SUBSEQUENT SAMPLES FOR A PATIENT ARE NOT RUN ON THE SAME INSTRUMENT. THE CUSTOMER CONSIDERED THE LH 500 RESULTS TO BE CORRECT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE, PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT AND NO INJURY OR DEATH WERE REPORTED EITHER. THE SAMPLES WERE FRESH BLOOD COLLECTED IN A 5ML EDTA VACUTAINER AT ROOM TEMPERATURE. DATA WAS SUBMITTED FOR FIVE REPRESENTATIVE PATIENT SAMPLES; AN INSTRUMENT GENERATED FLAG OF 'DIMORPHIC RED' IS PRESENT FOR EXAMPLE 4 ON THE DXH 800 PRINTOUT AND THE CORRECT RESULTS FOR EXAMPLE 2 ON THE LH 500 RUN. WBC IS OBSERVED TO BE LOW FOR EXAMPLES 1 AND 4. REVIEW OF DATA SUBMITTED FOR FIVE REPRESENTATIVE PATIENT SAMPLES DXH 800 RESULTS ARE CONSISTENTLY HIGHER THAN THOSE GENERATED BY THE LH 500; AN INSTRUMENT GENERATED FLAG OF 'DIMORPHIC REDS' IS PRESENT FOR EXAMPLE 4 ON THE DXH 800 PRINTOUT AND EXAMPLE 2 ON THE LH 500 RUN. WBC IS OBSERVED TO BE LOW FOR EXAMPLES 1 AND 4. PATIENT RESULTS ARE ATTACHED. THE UNIT CURRENTLY PERFORMING WITHIN PUBLISHED SPECIFICATIONS. CONTROLS RUN BEFORE AND AFTER THE INCIDENT RECOVERED WITHIN RANGE. THE CUSTOMER HAS RECALIBRATED BOTH ANALYZERS AND BOTH ARE WITHIN SPECS FOR QC AND IQAP. RAW DATA FILES ARE NOT AVAILABLE AS THEY HAD BEEN DELETED PRIOR TO CUSTOMER CONTACT FOR THIS ISSUE. REVIEW OF DATA SUBMITTED FOR FIVE REPRESENTATIVE PATIENT SAMPLES DXH 800 RESULTS ARE CONSISTENTLY HIGHER THAN THOSE GENERATED BY THE LH 500; AN INSTRUMENT GENERATED FLAG OF 'DIMORPHIC REDS' IS PRESENT FOR EXAMPLE 4 ON THE DXH 800 PRINTOUT AND EXAMPLE 2 ON THE LH 500 RUN. WBC IS OBSERVED TO BE LOW FOR EXAMPLES 1 AND 4.

    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. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR