BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2466432 · Received February 23, 2012

    Report

    Report Number
    1061932-2012-00658
    Event Type
    Injury
    Date Received
    February 23, 2012
    Date of Event
    January 21, 2012
    Report Date
    January 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2012 REPORTING OF ERRONEOUS COMPLETE BLOOD COUNT (CBC) RESULTS WHICH WERE GENERATED ON THE LH 500 HEMATOLOGY ANALYZER WITHOUT INSTRUMENT GENERATED FLAGS OR MESSAGES FOR TWO PATIENTS. CUSTOMER STATED THAT THE RESULTS WERE GENERATED USING CAPIJECT "BULLET" TUBES IN THE MANUAL MODE FOR THE TWO PATIENTS. CUSTOMER INDICATED THAT THE SAMPLES WERE REDRAWN AND RUN ON A FULL PURPLE TUBE IN AUTOMATIC MODE ON THE SAME LH 500 AND THE RESULTS OBTAINED WERE DIFFERENT AND CONSIDERED CORRECT. CUSTOMER NOTED THAT QC FOR BOTH MODES RECOVERED WITHIN EXPECTED RANGES BEFORE AND AFTER EACH EVENT. THIS REPORT IS FOR PATIENT #1 WHO HAD ERRONEOUS CBC RESULTS GENERATED ON (B)(6) 2012. PLEASE SEE MEDWATCH #1061932-2012-00642 FOR THE ERRONEOUS RESULTS GENERATED FOR PATIENT #2 ON (B)(6) 2012. ERRONEOUS (HIGH AND LOW) WHITE BLOOD CELLS (WBC), RED BLOOD CELLS (RBC), HEMOGLOBIN (HGB) AND CALCULATED HEMATOCRIT (HCT) RESULTS VARYING IN MAGNITUDE AND DIRECTION WERE GENERATED FOR TWO RUNS FROM THE SAME BULLET TUBE FOR PATIENT #1 ON (B)(6) 2012. UPON REVIEW OF THE INSTRUMENT PRINTOUTS PROVIDED BY THE CUSTOMER, IT WAS DISCOVERED THAT ERRONEOUS PLATELET (PLT) AND MEAN PLATELET VOLUME (MPV) RESULTS WERE ALSO GENERATED FOR THE FIRST RUN. CUSTOMER STATED THAT THE ERRONEOUS HGB RESULTS FROM THE FIRST RUN WERE REPORTED OUT OF THE LABORATORY AND PATIENT #1 WAS NOT TREATED AS A RESULT. LATER THAT DAY, THE LABORATORY TECHNICIAN OBSERVED A DISCREPANCY BETWEEN THE REPORTED RESULTS AND THE PATIENT'S HISTORY OF LOW HGB (6-7 RANGE), AND THE PATIENT WAS CALLED IN FOR A REDRAW. THE REDRAWN SAMPLE WAS THEN RUN IN AUTOMATIC MODE ON THE SAME LH 500 AND THE RESULTS WERE DETERMINED TO BE CORRECT AND REPORTED OUT OF THE LABORATORY. PATIENT #1 ULTIMATELY RECEIVED A TRANSFUSION, BUT TREATMENT WAS DELAYED BY AT LEAST 16 HOURS. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 AND VERIFIED THE INTEGRITY OF THE ASPIRATION SYSTEM AND DILUENT DISPENSERS, AND CHECKED NEEDLE PIERCING. FSE REPORTED THAT THE HGB LAMP WAS REPLACED BECAUSE IT SHOWED A DRIFT IN VOLTAGE. FSE NOTED THAT THE BLOOD SAMPLING VALVE (BSV) ACTUATOR WAS NOT ALWAYS ROTATING THE BSV PROPERLY AND REQUIRED A REPLACEMENT. BSV ACTUATOR WAS ALSO REPLACED AND REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. ROOT CAUSE FOR THE ERRONEOUS CBC RESULTS WAS ATTRIBUTED TO THE DEFECTIVE HGB LAMP AND BSV ACTUATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other