BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2042780 · Received April 7, 2011

    Report

    Report Number
    1061932-2011-00240
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIMEN COLLECTION OR STORAGE INFORMATION WAS PROVIDED. CONTROLS RUN BEFORE AND AFTER THE INCIDENT WERE WITHIN THE EXPECTED RANGE. THE UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND EXCHANGED THE FLOWCELL AND THE CABLE ASSAY FOR CONFIRMATION AND UPDATED THE INSTRUMENT SOFTWARE. RAW DATA ANALYSIS REVEALED THE EOSINOPHIL POPULATIONS OVERLAPPING WITH THE NEUTROPHIL POPULATIONS. THE OVERLAP SEEN FOR THE FIRST RUN LOOKED MORE SEVERE THAN THE OTHERS. DUE TO THIS SEVERE OVERLAP, THE ALGORITHM MISCLASSIFIES EOSINOPHILS AS NEUTROPHILS FOR THE FIRST RUN. THE INSTRUMENT WOULD HAVE FLAGGED THE RESULTS IF IT WAS SET TO "VERIFY DIFF" FLAG.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE COULTER LH 750 HEMATOLOGY ANALYZER GENERATED AN ERRONEOUS LOW EOSINOPHILS (EO%) AND HIGH NEUTROPHILS (NE%) RESULTS WITHOUT INSTRUMENT GENERATED FLAGS FOR ONE PATIENT SAMPLE. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE RESULTS WERE QUESTIONED AND THE SAME SPECIMEN WAS RERUN TWICE AND A MANUAL DIFFERENTIAL WAS PERFORMED. THE ERRONEOUS RESULTS CAUSED THE DOCTOR TO GIVE THE PATIENT AN ANTICANCER DRUG. A CORRECTED REPORT WAS SENT OUT AND THE PATIENT IS UNDERGOING CANCER TREATMENT. THERE WAS NO DEATH OR SERIOUS INJURY WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other