BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX COAGULATION ANALYZER

    MDR report key: 29723 · Received December 18, 1995

    Report

    Report Number
    1017272-1995-00008
    Event Type
    Malfunction
    Date Received
    December 18, 1995
    Report Date
    December 13, 1995
    Manufacturer
    DADE INTL., INC.
    Product Code
    GKP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    DISCORDANT PT RESULT WAS OBTAINED WHEN TESTING A SAMPLE USING THE COAGULATION ANALYZER. FLAT CURVE WITH NO ERROR CODE WAS OBTAINED FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST. THE RESULT OBTAINED ON THE ANALYZER WAS REPORTED. SUBSEQUENTLY, THE SAMPLE WAS VERIFIED AGAINST A BACK-UP INSTRUMENT AND THE RESULT OBTAINED ON THE FIRST INSTRUMENT WAS DISCORDANT. NO FURTHER INFO IS KNOWN AS TO THE STATUS OF THE PT. IT IS UNCLEAR WHETHER THE LABORATORY WAS FOLLOWING PROPER PRIMING/RINSING PROCEDURES FOR THE ANALYZER. THE RESULTS ARE AS FOLLOWS: CO'S PRODUCT DUPL 1 135 SEC (RESULT CONFIRMED ON DUPLICATE) AND BACK-UP INSTRUMENT 50 SEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX COAGULATION ANALYZER COAGULATION ANALYZER GKP DADE INTL., INC. CA-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 *