BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX HEMATOLOGY ANALYZER

    MDR report key: 18074217 · Received November 3, 2023

    Report

    Report Number
    MW5147774
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    October 15, 2023
    Report Date
    October 30, 2023
    Manufacturer
    SYSMEX AMERICA, INC.
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    XBARM ALARMED ON XNS-R AT 10:25 AM, UPON REVIEW OF THE FILTERED PATIENT RESULTS ALL THE MCV WERE DRAMATICALLY INCREASED. WE STOPPED RUNNING ON THE RIGHT SIDE OF THE SYSMEX--RAN LEVEL 2 QC WHICH ALARMED MCV ETC. WE CALLED TAC FOR HELP TROUBLESHOOTING, TAC REPLENISHED THE REAGENTS WNR LYSERCELL, WDF LYSERCELL, AND DFL. RAN QC STILL ALARMED OUT OF CONTROL. TAC PERFORMED RBC DETECTOR CLOG X3 AND CELL CEAN AS PATIENT X5, RERAN 3 LEVELS QC, ALL WITHIN RANGE. WHEN TAC WAS RUNNING THE RBC DETECTOR CLOG I REALIZED WE HAD A CLOTTED SPECIMEN ON THE RIGHT SIDE AT 8:00 A.M. THAT CAUSED THE SYSMEX TO BE CLOGGED AND AFFECTED THE MCV, HCT, AND PLATELET PARAMETERS. WE PULLED ALL SPECIMENS AFFECTED AFTER THE CLOTTED SPECIMEN AND RERAN THEM ON THE XNH IN MAIN HEMATOLOGY. ORGANIZED THE RESULTS, PERFORMED A RESULT CORRECTION IN EPIC FOR AFFECTED PATIENTS, APPROXIMATELY 60, AND CALLED THE CHARGE NURSE ON EACH FLOOR WITH PATIENT NAMES AND MRN WITH THE EXPLANATION THAT SOME CBC RESULTS WERE CORRECTED IN EPIC DUE TO A CLOTTED SAMPLE THAT COMPROMISED THE HEMATOLOGY INSTRUMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 12/22/23 FOR REPORT MW5147774 TO UPDATE EVENT DATE. REVISION TO A PREVIOUSLY SUBMITTED FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341224 SYSMEX HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ SYSMEX AMERICA, INC. XN3100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown