BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2172124 · Received June 15, 2011

    Report

    Report Number
    1061932-2011-00595
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    June 25, 2009
    Report Date
    June 25, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. ON (B)(4) 2009, A FIELD SERVICE ENGINEER VISITED THE SITE TO EVALUATE THE ANALYZER. HE ADJUSTED THE FLOWCELL, LIGHT SCATTER AND GAINS AND VERIFIED INSTRUMENT OPERATION. THE RAW DATA FROM THIS SAMPLE WERE NOT AVAILABLE FOR ANALYSIS. THE ROOT CAUSE(S) OF THE ERRONEOUS RESULTS IS (ARE) UNK, ALTHOUGH THE HARDWARE ADJUSTMENTS PERFORMED DURING INSTRUMENT SERVICE MAY HAVE CORRECTED ANY UNDERLYING MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2009 THE LH750 HEMATOLOGY ANALYZER GENERATED AN ERRONEOUSLY HIGH NEUTROPHIL COUNT AND A FALSELY LOW EOSINOPHIL COUNT ON ONE PT SAMPLE. THE TEST RESULTS WERE ACCOMPANIED BY TWO INSTRUMENT-GENERATED FLAGS FOR IMMATURE NEUTROPHILS. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND WERE QUESTIONED BY THE PHYSICIAN. A MANUAL DIFFERENTIAL WAS PERFORMED AND A CORRECTED REPORT WAS SUBSEQUENTLY ISSUED. THERE WERE NO REPORTED CHANGES TO PT TREATMENT AS A RESULT OF THIS INCIDENT.

    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 53 YR