BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2223195 · Received August 12, 2011

    Report

    Report Number
    1061932-2011-01167
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    October 30, 2009
    Report Date
    October 30, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS MDR IS FOR ANALYZER 1 OF 2. SEE MDR# 1061932-2011-01168 FOR ANALYZER 2 OF 2. THE SAMPLE WAS COLLECTED IN A 4 ML VACUTAINER TUBE. RAW DATA WERE REQUESTED FOR ANALYSIS BUT NOT PROVIDED BY THE CUSTOMER. A FIELD SERVICE ENGINEER VISITED THE SITE ON (B)(4) 2010 AND VERIFIED THE INSTRUMENT'S OPERATION. THE ROOT CAUSE IS UNK; HOWEVER, PER BECKMAN COULTER INC LABELING, ERYTHROCYTE INCLUSIONS STAINED BY NEW METHYLENE BLUE, IF SUFFICIENTLY NUMEROUS WITHIN A SAMPLE, AND SOME HEMOGLOBINOPATHIES (SUCH AS SICKLE CELL ANEMIA) MIGHT AFFECT THE ACCURACY OF THE RETICULOCYTE ENUMERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LH750 HEMATOLOGY ANALYZER GENERATED AN ERRONEOUSLY HIGH RETICULOCYTE COUNT (14.68%) ON A SAMPLE FROM ONE PT. THE TEST RESULTS WERE ACCOMPANIES BY INSTRUMENT GENERATED MESSAGES FOR CELLULAR INTERFERENCE, NUCLEATED RED BLOOD CELLS AND DIMORPHIC RED BLOOD CELLS. THE RETICULOCYTE TEST RESULTS WERE FLAGGED WITH "H" FOR HIGH RESULTS. THE ERRONEOUS TEST RESULTS WERE REPORTED OUTSIDE OF THE LAB. A MANUAL RETICULOCYTE COUNT WAS SUBSEQUENTLY PERFORMED WITH A RESULT OF 4.3%. THE CUSTOMER BELIEVED THE MANUAL COUNT TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED. THERE WERE NO REPORTED CHANGES TO PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK