BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2183622 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00828
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 17, 2008
    Report Date
    April 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS PERFORMING WITHIN QUALITY CONTROL (QC) SPECIFICATIONS. CONTROLS WERE RUN EACH SHIFT AND WERE RUN BEFORE AND AFTER THE INCIDENT WITH RECOVERY WITHIN QC RANGE. ON (B)(6) 2008, THE FIELD SERVICE ENGINEER REPLACED AND ALIGNED THE FLOW CELL AND PERFORMED A TRIPLE TRANSDUCER MODULE OPTIMIZATION. RAW DATA ANALYSIS WAS CONDUCTED AND DETERMINED THAT THE NEUTROPHIL/EOSINOPHIL POPULATIONS WERE MERGED INTO ONE OVERLAP PATTERN, WITH LITTLE DISTINCTIVE VALLEY BETWEEN THE TWO POPULATIONS. THIS WEAK VALLEY BETWEEN THE TWO POPULATIONS RESULTED IN THE INCORRECT EOSINOPHIL% REPORT BY THE LH750. THE ROOT CAUSE FOR THE ERRONEOUS DIFFERENTIALS IS THE ALGORITHM COULD NOT REPORT THE CORRECT EOSINOPHIL PERCENT DUE TO THE WEAK VALLEY BETWEEN NEUTROPHIL/EOSINOPHIL POPULATIONS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS LOW EOSINOPHIL% ON DIFFERENTIAL WAS OBTAINED WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON A RERUN ON A COULTER GEN-S SYSTEM AND THE MANUAL BLOOD SMEAR DIFFERENTIAL. BOTH DEMONSTRATED HIGHER EOSINOPHIL%. THERE WERE NO INSTRUMENT GENERATED FLAGS WITH THE RESULTS. ERRONEOUS TEST RESULTS WERE NOT RELEASED FROM THE LAB. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO EFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    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