BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2171232 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00775
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 27, 2008
    Report Date
    March 28, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS PERFORMING WITHIN QUALITY CONTROL SPECIFICATIONS. CONTROLS WERE RUN BEFORE THE INCIDENT AND RECOVERED WITHIN RANGE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. RAW DATA ANALYSIS WAS CONDUCTED. THE RAW DATA ANALYSIS IDENTIFIED TWO CLUSTERS IN NEUTROPHIL-EOSINOPHIL REGION. THE TWO CLUSTERS WERE MERGED TOGETHER. LH500 SOFTWARE ALGORITHM DETECTED THIS AS AN ABNORMAL DISTRIBUTION PATTERN AFTER GATING BOTH CLUSTERS AS NEUTROPHIL CELLS AND GENERATED VERIFY DIFF, IMM NE1, AND IMM NE2 MESSAGES. BASED ON THE RAW DATA ANALYSIS, THE ROOT CAUSE FOR ERRONEOUS DIFFERENTIAL RESULTS MAY BE ATTRIBUTED TO THE SAMPLE'S NEUTROPHIL/EOSINOPHIL POPULATIONS MERGING TOGETHER. FURTHERMORE, THE SYSTEM ADEQUATELY FLAGGED THE SAMPLE PROMPTING THE OPERATOR FURTHER REVIEW THE RESULTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL TEST RESULTS WITH LOW EOSINOPHIL% WHEN USING A COULTER LH 500 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE FLAGGED WITH INSTRUMENT GENERATED FLAGS. THE OPERATOR PERFORMED A MANUAL BLOOD SMEAR AND CONFIRMED LOW EOSINOPHIL%. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULTS AS DIFFERENT FROM PATIENT'S HISTORY OF EOSINOPHILIA. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON COMPARISON WITH A REREAD OF THE MANUAL BLOOD SMEAR DIFFERENTIAL WHICH OBSERVED HIGH EOSINOPHIL%. THE CUSTOMER ALSO SENT THE SAMPLE TO ANOTHER LABORATORY THAT CONFIRMED HIGH EOSINOPHIL%. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 500 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK