BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX CA-1000

    MDR report key: 29724 · Received December 20, 1995

    Report

    Report Number
    1017272-1995-00009
    Event Type
    Malfunction
    Date Received
    December 20, 1995
    Date of Event
    December 8, 1995
    Report Date
    December 20, 1995
    Manufacturer
    DADE INTL., INC.
    Product Code
    GKP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISCORDANT PT RESULTS WERE OBTAINED WHEN TESTING A HEPARINIZED SAMPLE USING THE COAGULATION ANALYZER. FLAT CURVES WITH NO ERROR CODE WERE OBTAINED FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST. THE RESULTS OBTAINED ON THE ANALYZER WERE NOT REPORTED. THE SAMPLE WAS ALSO TESTED WITH A REFERENCE METHOD AND THIS RESULT WAS REPORTED. THE RESULTS OBTAINED ARE AS FOLLOWS: APTT ON CO'S PRODUCT, SPECIMENT/RUN 1 = 9.9 SEC* (REFERENCE = 120 SEC), SPECIMEN/RUN 2 = 11.0 SEC*, SPECIMENT/RUN 3 = 97.9 SEC (*FLAT CURVES WITH NO ERROR CODE WERE OBSERVED WITH THESE RUNS).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *