BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMATOLOGY ANALYZER

    MDR report key: 513360 · Received March 1, 2004

    Report

    Report Number
    513360
    Event Type
    Other
    Date Received
    March 1, 2004
    Date of Event
    August 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    SYSMEX AMERICA, INC.
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2003 THIS PT PRESENTED TO THE E.D. [EMERGENCY DEPARTMENT] WITH COMPLAINTS OF WEAKNESS AND INDIGESTION. A ROUTINE CBC SPECIMEN WAS SENT TO THE HEMATOLOGY LAB. THE OPEN MODE OF THE SYSMEX SE9000 HEMATOLOGY ANALYZER WAS USED TO OBTAIN THE COUNT. PER LAB PROTOCOL, THE SPECIMEN WAS ANALYZED 2 TIMES TO VERIFY THE RESULTS OF 7.5G/DL HEMOGLOBIN OBTAINED. AFTER VERIFICATION, THE RESULTS WERE RELEASED TO THE E.D. STAFF. ONE DAY LATER, 1 UNIT OF PRBCS TRANSFUSED TO THE PT. POST TRANSFUSION UNEXPECTEDLY HIGH (13.9/40.5). THE QUESTIONABLE SPECIMEN WAS REPEATED TO CHECK THE PREVIOUS RESULTS. IT WAS IDENTIFIED THAT THE SYSMEX SE9000 ANALYZER DUPLICATED THE INCORRECT HGB VALUE. THE LABORATORY STOPPED USING THE OPEN MODE ON THE SE9000 AND THE FIELD ENGINEER WAS CALLED AND REPAIRED THE INSTRUMENT. ONCE REPAIRED, PRECISION STUDIES WERE DONE TO VERIFY THAT BOTH BLOOD ANALYZING MODES, AUTOMATED MODE AND OPEN MODE (MANUAL MODE) WERE PRODUCING PRECISE AND ACCURATE LABORATORY RESULTS. THE PT WAS MADE AWARE OF THE INACCURATE RESULTS AND WAS DISCHARGED HOME IN STABLE CONDITION ONE DAY LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ SYSMEX AMERICA, INC. SE9000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other