BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XE-5000 ANALYZER

    MDR report key: 4095289 · Received June 27, 2014

    Report

    Report Number
    3009711478-2014-00015
    Event Type
    Other
    Date Received
    June 27, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 28, 2014
    Manufacturer
    SYSMEX CORP.
    Product Code
    GKZ
    PMA / PMN Number
    K071967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE XE-5000 ANALYZER IS INTENDED TO BE USED FOR IN VITRO DIAGNOSTIC USE IN SCREENING PT POPULATIONS FOUND IN CLINICAL LABORATORIES. THE ANALYZER ALERTED THE OPERATOR TO SAMPLE ABNORMALITY BY: POSITIVE JUDGMENTS; INTERPRETIVE PROGRAM MESSAGES, ASTERISKS NEXT TO THE VALUES. THESE MESSAGES ARE INTENDED TO ALERT THE OPERATOR SO THAT VERIFICATION OF RESULTS ARE DONE PRIOR TO REPORTING. THE SAMPLES WERE RUN ORIGINALLY FOR CBC + DIFF. PLATELETS ARE MEASURED BY IMPEDANCE TESTING, LARGELY BASED ON SIZE. CLUMPED PLATELETS ARE LARGER THAN SINGLE PLATELETS. MANUAL REVIEW OF A SMEAR COMMONLY IS PERFORMED TO CHECK FOR PLATELET CLUMPS AND AN ESTIMATE CAN BE COMPARED TO THE AUTOMATED RESULT. THE USER PERFORMED NO MANUAL REVIEW OF A SMEAR UNTIL(B)(6) , EVEN AFTER OBTAINING ABNORMAL RESULTS ON PREVIOUS DAYS. ANOTHER METHOD TO VERIFY PLATELET VALUES IS RE-ANALYSIS USING ADDITIONAL CHANNELS, INCLUDING THE RETICULOCYTE CHANNEL. AN OPTICAL MEASUREMENT USING FLOW CYTOMETRY MAY PROVIDE MORE INFO WHEN IMPEDANCE COUNTS ARE FLAGGED DUE TO SAMPLE INTERFERENCE. THE OPTICAL PLATELETS GENERATED FROM THIS PT'S SAMPLE FELL WITHIN NORMAL VALUES. HAD THESE VALUES BEEN REPORTED, NO PLATELET TRANSFUSION WOULD HAVE BEEN ORDERED. THE USER DID NOT FOLLOW DIRECTIONS IN THE SYSMEX XE-5000 INSTRUCTIONS FOR USE OR SOFTWARE GUIDE TO INVESTIGATE AND RESOLVE ABNORMALITIES IN THIS PT'S SAMPLE. USER ERROR CAUSED THIS PT TO RECEIVE A TRANSFUSION OF PLATELETS UNNECESSARILY, WITH THE POTENTIAL RISK OF INFECTION, EXPOSURE TO BLOOD BORNE PATHOGENS AND TRANSFUSION REACTION.

    Description of Event or Problem · 1

    THE XE-5000 OPERATOR REPORTED TO THE SYSMEX TECHNICAL ASSISTANCE CENTER (TAC) ON (B)(6) 2014, THAT ERRONEOUS LOW PLATELET RESULTS WERE GENERATED ON PT SAMPLES FROM A SINGLE PT. SAMPLES WERE COLLECTED IN ETHYLENEDIAMINE-TETRAACETIC ACID (EDTA). PLATELET VALUES ON THE FIRST SEVEN SAMPLES WERE BETWEEN 9 AND 38 X 10^3/ UL. PLATELET CLUMPS WERE DISCOVERED IN THE SEVENTH SAMPLE ON (B)(6). THE PT WAS TRANSFUSED WITH SINGLE-DONOR PLATELETS ON (B)(6) 2014 AT 1836. THE ANALYZER JUDGED ALL PREVIOUS SAMPLES MEASURING PLATELETS AS "POSITIVE", AN INDICATION OF SAMPLE ABNORMALITY, WITH INTERPRETIVE PROGRAM (IP) MESSAGES FOR THROMBOCYTOPENIA, PLT ABNORMAL DISTRIBUTION AND PLT CLUMPS. OPERATORS DID NOT PERFORM MANUAL SMEAR REVIEW UNTIL (B)(6) WHEN PLATELET CLUMPS WERE DISCOVERED. THE PT THEN WAS DRAWN IN A COLLECTION TUBE CONTAINING SODIUM CITRATE AND THE PLATELET COUNT FROM THE ANALYZER WAS 318 X 10^3/UL. THE PT SUFFERED NO ILL EFFECTS AS A RESULT OF THE PLATELET TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376920 SYSMEX XE-5000 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORP. XE-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other