BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XE-5000 ANALYZER

    MDR report key: 3772124 · Received April 8, 2014

    Report

    Report Number
    3009711478-2014-00007
    Event Type
    Other
    Date Received
    April 8, 2014
    Date of Event
    March 9, 2014
    Report Date
    March 10, 2014
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K071967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATORS MANUAL CONTAINS A CHAPTER LISTING POTENTIAL SAMPLE INTERFERENCES THAT CAN BE EXPECTED AND ALERTS THE OPERATOR TO POTENTIAL PRE-ANALYTIC SAMPLE CONDITIONS THAT COULD IMPACT PT RESULTS. THE ORIGINAL SPECIMEN WAS DRAWN BY AN ER NURSE, POSSIBLY OFF AN INITIAL IV STICK. THE OPERATOR INDICATED SPECIMENS DRAWN BY ER NURSES ARE OFTEN CLOTTED. THE OPERATOR SUSPECTS IT MAY HAVE BEEN CLOTTED DUE TO THE VARIATION IN HGB VALUES BETWEEN ANALYSES. ALL OF THE ANALYSES WERE JUDGED "POSITIVE" WITH MULTIPLE IP MESSAGES INDICATING POSSIBLE SAMPLE ABNORMALITY REQUIRING FURTHER VERIFICATION (SUCH AS REPEAT ANALYSIS OR PERIPHERAL SMEAR REVIEW) PRIOR TO REPORTING RESULTS. RESULTS FROM (B)(6) 2014 03:51 AND 04:11 APPEAR TO HAVE BEEN INADEQUATELY MIXED BY THE OPERATOR PRIOR TO MANUAL SAMPLE ASPIRATION. THIS IS INDICATED BY THE HIGH RBC AND HGB AND LOW WBC AND PLT VALUES. THE OPERATOR'S MANUAL INSTRUCTS THE OPERATOR TO MIX THE SAMPLE THOROUGHLY BY INVERSION PRIOR TO MANUAL SAMPLE ASPIRATION. REVIEW OF PREVIOUS RESULTS INDICATE THE PT'S HGB CONCENTRATION WAS DECREASING SLIGHTLY EACH DAY. IT IS NOT UNCOMMON TO TRANSFUSE PACKED RBCS FOR PTS WHOSE HGB CONCENTRATION IS BELOW NORMAL REFERENCE RANGES. NORMAL HGB CONCENTRATION FOR AN ADULT MALE PT IS 13.7-17.5 G/DL THE PT HAD BEEN RECOVERING NEAR 8 G/DL. THE CLINICAL DECISION TO TRANSFUSE PACKED RBCS COULD NOT BE VERIFIED. THIS ISSUE WILL BE REPORTED ON THE BASIS THAT ERRONEOUS RESULTS MAY HAVE CONTRIBUTED TO A PT RECEIVING A POTENTIALLY UNNECESSARY TRANSFUSION, CARRYING WITH IT THE RISKS INVOLVED WITH RECEIVING BLOOD PRODUCTS: TRANSFUSION REACTION, DEVELOPMENT OF ANTIBODIES, ETC.

    Description of Event or Problem · 1

    THE XE-5000 OPERATOR REPORTED TO THE SYSMEX TECHNICAL ASSISTANCE CENTER ON (B)(6) 2014, THAT THEY REC'D ERRATIC WHITE BLOOD CELL (WBC) RESULTS BETWEEN ANALYSES ON AN ER PT, SAMPLE ID (B)(6). THE SAMPLE WAS TESTED ON (B)(6) 2014 AT 03:38. THE ANALYZER JUDGED THE SAMPLE WAS "POSITIVE" WITH MULTIPLE INTERPRETIVE PROGRAM (IP) MESSAGES AND FLAGS. THE OPERATOR PERFORMED SEVERAL REPEAT ANALYSES IN THE MANUAL MODE, EACH "POSITIVE" WITH IPG MESSAGES. VARIATION OF RESULTS BETWEEN WBC, HEMOGLOBIN (HGB) AND PLATELETS (PLT) WAS OBSERVED. THE RESULTS FROM THE (B)(6) 2014 04:23 ANALYSIS WERE REPORTED WITH THE HGB=6.5 G/DL, ON PREVIOUS ANALYSES HGB=8.1 TO 8.6 G/DL. THE OPERATOR COULD NOT CONFIRM THE REPORTED RESULTS WERE ACCURATE, AND IT IS UNK IF SAMPLE INTEGRITY WAS INVESTIGATED. THE OPERATOR PERFORMED MANUAL SMEAR REVIEW, HOWEVER DATA WAS NOT PROVIDED. THE PT WAS TRANSFUSED WITH ONE UNIT OF PACKED RED BLOOD CELLS (PRBC) ON (B)(6) 2014. THE PHYSICIAN MAY HAVE TRANSFUSED BASED ON THE LOW HGB=6.5 VALUE. A SUBSEQUENT SAMPLE WAS DRAWN AFTER THE TRANSFUSION THE FOLLOWING DAY, SAMPLE ID (B)(6) . IT IS UNK IF DELTA CHECKING IS USED AT THIS LABORATORY. THE PT SUFFERED NO ILL EFFECTS AS A RESULT OF THE TRANSFUSION OF ONE UNIT OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212175 SYSMEX XE-5000 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XE-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other