BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2161056 · Received June 17, 2011

    Report

    Report Number
    1061932-2011-00607
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    November 21, 2008
    Report Date
    November 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED A CYCLE CLEAN AFTER THE INITIAL RUN AND RERAN THE SAMPLE RECOVERING LOWER RESULTS. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER (FSE) REMOVED AND CLEANED THE WBC APERTURE. ALSO REPLACED O-RINGS AND TUBES. VERIFIED ANALYZER MET PERFORMANCE SPECS. BASED ON THE AVAILABLE INFO, THE ROOT CAUSE FOR ERRONEOUS WBC RESULTS IS UNK, BUT MAY BE ATTRIBUTED TO PARTS REPLACED BY THE FSE. 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. THIS MDR REPRESENTS EVENT 2 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00606.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH WHITE BLOOD CELL (WBC) COUNT OF 64.7 X 10 TO THE THIRD POWER CELLS/ UL WHEN USING A COULTER LH 500 HEMATOLOGY ANALYZER. THE WBC TEST RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON RERUN TEST RESULTS OF 42.8 X 10 TO THE THIRD POWER CELLS/UL AND RERUN ON THE COULTER ACT 5DIFF HEMATOLOGY ANALYZER OF 44.6 X 10 TO THE THIRD POWER CELLS/UL. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. THE DOCTOR WAS NOTIFIED OF THE CORRECT RESULTS. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 2 OF 2 EVENTS REPORTED BY THIS CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR