BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2160265 · Received June 2, 2011

    Report

    Report Number
    1061932-2011-00543
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    August 25, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE INFORMATION WAS NOT AVAILABLE. RAW DATA ANALYSIS WAS CONDUCTED AND DETERMINED THAT THE WBC HISTOGRAMS SHOWED SEVERE INTERFERENCE PATTERNS. ROOT CAUSE WAS DETERMINED TO BE UNLYSED RED BLOOD CELLS IN THE WBC HISTOGRAM CAUSING SEVERE INTERFERENCE. PRODUCT LABELING STATES THAT INSTRUMENT GENERATED MESSAGES ALERT THE OPERATOR TO FURTHER REVIEW THE SAMPLE. LYSE RESISTANT RED CELLS ARE LISTED AS KNOWN INTERFERING SUBSTANCES FOR THE WBC PARAMETER. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 2 OF 3 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00541, 1061932-2011-00544.

    Description of Event or Problem · 1

    ON (B)(6) 2008, CUSTOMER REPORTED ELEVATED AND INCONSISTENT UNCORRECTED WBC (WHITE BLOOD COUNT) FOR A SPECIFIC SAMPLE WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE GENERATED ON (B)(6) 2008 AND WERE FLAGGED WITH INSTRUMENT GENERATED MESSAGES FOR THE WBC PARAMETER. THE WBC TEST RESULTS WERE COMPARABLE TO A MANUAL COUNT OF 9.0 X 10 TO THE 3RD POWER CELLS/UL. THE MANUAL COUNT WAS REPORTED AS CORRECT. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 2 OF 3 EVENTS REPORTED BY THIS CUSTOMER FOR THE SAME PATIENT.

    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