BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX CA-1500 ANALYZER

    MDR report key: 3772126 · Received April 11, 2014

    Report

    Report Number
    3009711478-2014-00009
    Event Type
    Other
    Date Received
    April 11, 2014
    Report Date
    March 27, 2014
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKP
    PMA / PMN Number
    K993299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE PLASMA WAS CLEAR, FREE OF CLOTS AND LESS THAN 4 HRS OLD. THE OPERATOR DISPENSES ALL SAMPLES INTO 4ML SAMPLE CUPS FOR ANALYSIS ON THE ANALYZER. THE OPERATOR CONFIRMED ANALYZER PERFORMANCE WITH QUALITY CONTROL AFTER THE EVENT OCCURRED. THE OPERATOR ALSO CONFIRMED ANALYZER REPRODUCIBILITY BY PERFORMING A PRECISION CHECK. BOTH QC AND PRECISION PASSED WITHIN LABORATORY'S SPECIFICATION. THE OPERATOR DECLINED FIELD SERVICE ENGINEER (FSE) DISPATCH. RECENT SERVICE ON (B)(6) 2014 WAS PERFORMED AND UNIT WAS OPERATIONAL AT THAT TIME. REVIEW OF THE SAMPLE RESULT FOR INITIAL PT WAS 19.0 SECONDS WITH REPEAT ANALYSIS RESULT OF 9.8 SECONDS. ROOT CAUSE OF THE SIGNIFICANT DIFFERENCE BETWEEN ANALYSES WAS NOT DETERMINED AT THE TIME OF THIS ASSESSMENT. SAMPLE HANDLING AND ANALYZER PERFORMANCE COULD NOT BE RULED OUT. THIS INCIDENT IS REPORTED AS ROOT CAUSE OF THE OCCURRENCE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE USER OF A SYSMEX CA-1500 S/N (B)(4) REPORTED TO SIEMENS HEALTHCARE DIAGNOSTICS ON (B)(4) 2014 REGARDING ERRONEOUS RESULTS GENERATED FOR INTERNATIONAL NORMALIZED RATIO (INR). THE USER ANALYZED A SAMPLE FROM AN ER PT SUSPECTED OF SUFFERING A STROKE. THE INITIAL RESULT INR=1.82, PROTHROMBIN TIME (PT) WAS 19.0 SECONDS, RESULTS REPORTED. THE ER DOCTOR QUESTIONED THE RESULT BECAUSE THE LABORATORY RESULTS DID NOT MEET CRITERIA TO ADMINISTER TISSUE PLASMINOGEN ACTIVATOR (TPA); INR <1.7. THE DR REQUESTED A REDRAW. THE REDRAW RESULT INR=1.03. THE OPERATOR ANALYZED QC AND PARAMETERS WERE WITHIN THE LAB'S SPECIFIED RANGE. THE OPERATOR THEN PERFORMED PRECISION WHICH PASSED. REPEAT ANALYSIS ON THE INITIAL DRAW WAS PT 9.8 SECONDS, INR 0.97. THE OPERATOR SEN THE INITIAL DRAW TO THE MAIN LAB FOR REPEAT ANALYSIS ON A BEHRING COAGULATION SYSTEM (BCS) ANALYZER, MODEL UNK, AND GENERATED AN INR OF 1.02. REPEAT ANALYSIS AND NEW SAMPLE COLLECTION DELAYS POTENTIAL TPA TREATMENT FOR PTS WHO PRESENT WITH SYMPTOMS OF STROKE. THIS PT WAS EXCLUDED AS A CANDIDATE FOR TPA FOR OTHER CRITERIA. THE OCCURRENCE WAS REPORTED TO SYSMEX AMERICA, INC ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221584 SYSMEX CA-1500 ANALYZER AUTOMATED BLOOD COAGULATION ANALYZER GKP SYSMEX CORPORATION CA-1500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention