BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2172128 · Received June 15, 2011

    Report

    Report Number
    1061932-2011-00587
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED FRESH IN A GREINER K2 EDTA 5ML TUBE. CONTROLS WERE RUN BEFORE THE PT SAMPLE AND WERE WITHIN ACCEPTABLE LIMITS. THE UNIT WAS PERFORMING WITHIN QUALITY CONTROL SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. RETICULOCYTE CONTROL LEVEL 1 WAS RUNNING HIGH ON (B)(6) 2008. NOTE: K2 EDTA = POTASSIUM ETHYLENEDIAMINETETRACETIC ACID. FIELD SERVICE OPTIMIZED THE INSTRUMENT AND PERFORMED INSTRUMENT VERIFICATION ON (B)(6) 2008. ROOT CAUSE MAY BE SAMPLE RELATED. THE SAMPLE MAY HAVE SMALL LYMPHOCYTE CELLS. THE NRBC CELLS MAY HAVE MERGED TOGETHER WITH THE LYMPHOCYTES IN THE WBC HISTOGRAM. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 3 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00588, 1061932-2011-00589.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS NUCLEATED RED BLOOD CELL (NRBC) TEST RESULTS OF 0 (ZERO) WERE OBTAINED WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER ON (B)(6) 2008. THE ERRONEOUS TEST RESULTS OCCURRED WITH A SPECIFIC PT SAMPLE. THERE WERE NO INSTRUMENT GENERATED FLAGS SPECIFIC FOR NRBC. THERE WAS AN INSTRUMENT GENERATED DIFFERENTIAL FLAG AND A MANUAL DIFFERENTIAL WAS PERFORMED, YIELDING 9 NRBC SEEN DURING A 100 CELL DIFFERENTIAL. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 1 OF 3 EVENTS REPORTED BY THIS CUSTOMER FOR THE SAME PT TESTED ON THREE SEPARATE OCCASIONS. THIS REPORT IS FOR THE TESTING PERFORMED ON (B)(6) 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK