BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX CA-1000

    MDR report key: 28784 · Received November 17, 1995

    Report

    Report Number
    1017272-1995-00002
    Event Type
    Malfunction
    Date Received
    November 17, 1995
    Date of Event
    November 3, 1995
    Report Date
    November 15, 1995
    Manufacturer
    TOA MEDICAL ELECTRONICS
    Product Code
    KQG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    DISCORDANT PT RESULTS WERE OBTAINED WHEN TESTING A SPECIMEN USING ANALYZER. DISCORDANT PROTHROMBIN TIME (PT=134 SEC) RESULT WITH A GOOD CURVE WAS OBTAINED ON THE INITIAL SPECIMEN. THIS SPECIMEN TESTED AGAINST A REFERENCE METHOD YIELDED A PT RESULT OF 42 SECONDS. SUBSEQUENT SPECIMEN TESTED ON THE DEVICE YIELDED A PT RESULT OF 32.1 SECONDS. CONTROLS WERE WITHIN RANGE. RESULTS ON THE DEVICE ANALYZER WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX CA-1000 COAGULATION ANALYZER KQG TOA MEDICAL ELECTRONICS CA-1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other