BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2352182 · Received November 29, 2011

    Report

    Report Number
    1061932-2011-02471
    Event Type
    Malfunction
    Date Received
    November 29, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 3, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FSE MEASURED AND ADJUSTED THE DIFFERENTIAL PUMP VOLUMES.

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2011 REPORTING THAT THEIR LH 500 HEMATOLOGY ANALYZER WAS GENERATING ERRONEOUS HIGH BASOPHILS (BA) WITH NO INSTRUMENT GENERATED FLAGS FOR APPROXIMATELY 70% OF HIS PATIENT SAMPLES. THE ERRONEOUS RESULTS DISPLAYED A USER-DEFINED 'H' FLAG (RESULT IS HIGHER THAN YOUR REFERENCE INTERVAL HIGH LIMIT) IN EACH INSTANCE AND CUSTOMER PROVIDED RESULTS FOR 3 PATIENT SAMPLES. CUSTOMER STATED THAT NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB AS THE SAMPLES WERE RERUN ON ANOTHER INSTRUMENT (LH 780). CUSTOMER QUESTIONED THE RESULTS BECAUSE BASOPHILS (BA) VALUES DID NOT MATCH RESULTS GENERATED BY THE LH 780. NO INJURY OR AFFECT TO PATIENT TREATMENT WAS REPORTED AS A RESULT OF THIS EVENT. THIS REPORT IS FOR THE ERRONEOUS RESULTS GENERATED FOR PATIENT #1 AND PATIENT #2 WHICH OCCURRED ON (B)(6) 2011. PLEASE SEE MEDWATCH #1061932-2011-02483 FOR THE REPORT ON PATIENT #3. REVIEW OF THE PRINTS SHOWED HIGH NEUTROPHILS (NE) AND LOW LYMPHOCYTES (LY) AS WELL AS HIGH BASOPHILS (BA). FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THE SCATTERPLOT MISCUT OVER LYMPHOCYTE POPULATION DUE TO A CHEMISTRY MISMATCH CAUSED BY LEAK AT THE PELTIER MODULE. FSE PROCEEDED TO REPLACE THE DIFF SAMPLE LINE, THE BLOOD SAMPLE VALVE (BSV) ERYTHROLYSE LINE, THE REAGENT PAK, AND SHEATH LINES FROM THE PELTIER. FSE THEN MEASURED AND ADJUSTED THE DIFFERENTIAL PUMP VOLUMES AND VERIFIED REPAIRS PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1