BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2353952 · Received December 1, 2011

    Report

    Report Number
    1061932-2011-02420
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND STORAGE INFORMATION WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) INDICATED THAT THE WHITE BLOOD CELL (WBC) HISTOGRAM WAS SHIFTED NOTICEABLY TO THE LEFT, WITH LYMPH POPULATION STARTING AT ABOUT 35FL. FSE NOTED HEAVY BROWN BUILDUP SEEN ON INTERNAL ELECTRODES. FSE BLEACHED INTERNAL ELECTRODES (WHITE BLOOD CELL & RED BLOOD CELL), RAN LATEX PARTICLES AND ADJUSTED WBC APERTURE VOLTAGES UP. WBC HISTOGRAM THEN SHIFTED BACK TO THE RIGHT TO ITS NORMAL POSITION. PATIENT SAMPLES WERE RUN AND NRBC VALUES WERE 0%. PER LABELING, ALL NRBC% RESULTS > 2 AND < 15 WILL BE FLAGGED WITH AN R SYMBOL. BECKMAN COULTER, INC. RECOMMENDS A SLIDE REVIEW AS PER YOUR INDIVIDUAL LABORATORY PROTOCOL. THE PRESENCE OF THIS FLAG DOES NOT AFFECT THE CORRECTION OF THE WHITE BLOOD CELL COUNT IN THE PRESENCE OF NRBCS. RELATED MDRS: 1061932-2011-02417, 1061932-2011-02419, 1061932-2011-02420, 1061932-2011-02431, 1061932-2011-02434. AS PART OF A RETROSPECTIVE REVIEW, THIS EVENT WAS DETERMINED TO BE REPORTABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THE COULTER LH 750 HEMATOLOGY ANALYZER INTERMITTENTLY GENERATING FALSE POSITIVE NUCLEATED RED BLOOD CELLS (NRBC) DURING THE PERIOD FROM (B)(6) 2011. THE CUSTOMER PROVIDED INSTRUMENT PRINTOUTS FOR FIVE (5) DIFFERENT PATIENTS. EACH OF THE PATIENT SAMPLE RESULTS HAD INSTRUMENT GENERATED R FLAGS. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. PATIENT SPECIMENS WERE REPEATED AND 0% NRBC VALUES WERE OBTAINED. THE CUSTOMER DID NOT PROVIDE RERUN PRINTOUTS. ADDITIONALLY, NO NRBCS WERE OBSERVED BY A MANUAL SCAN. CORRECTED REPORTS WERE SENT OUT. THIS REPORT REPRESENTS THE RESULT GENERATED ON (B)(6) 2011. NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1