BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2823430 · Received November 8, 2012

    Report

    Report Number
    1061932-2012-02676
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND NOTED NO HARDWARE ISSUES. THE INSTRUMENT WAS PERFORMING WITHIN THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE LABORATORY PERFORMS DAILY MODE-TO-MODE VERIFICATION PROCEDURE, WHICH PASSED WITH ACCEPTABLE COEFFICIENT OF VARIATION (CV) LIMITS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS ANALYTE RESULTS THROUGH MANUAL MODE, FOR TWO PATIENTS, INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. SAMPLE #1 INDICATES THE INITIAL MANUAL MODE RESULTS RECOVERED LOWER FOR WHITE BLOOD CELL (WBC), HEMOGLOBIN (HGB), MEAN CELL HEMOGLOBIN (MCH) AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) AND SLIGHTLY HIGHER FOR RED BLOOD CELL (RBC) RESULTS WITHOUT INSTRUMENT GENERATED FLAGS. THE HEMOGLOBIN AND HEMATOCRIT (H&H) RATIO DID NOT CORRELATE ON THE INITIAL ANALYSIS. SAMPLE #2 WAS ANALYZED FIVE TIMES IN THE MANUAL MODE. THE H&H RATIO DID NOT CORRELATE ON THE REANALYSIS, WHICH RECOVERED LOW WBC AND HIGH RBC AND PLT WITHOUT INSTRUMENT GENERATED MESSAGES EXCEPT FOR RETEST #1 AND #3. SUBSEQUENT ANALYSIS OF THE PATIENT SAMPLE, ON THE SAME INSTRUMENT, RECOVERED HIGHER RESULTS WHICH WERE CONSIDERED TO BE CORRECT. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY, AND AMENDED REPORTS WERE ISSUED. THERE WAS NO IMPACT TO PATIENT OUTCOME. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1