BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1811632 · Received August 23, 2010

    Report

    Report Number
    1319681-2010-00169
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 25, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE FALSELY ELEVATED VITROS TROP I ES RESULT OCCURRED ON ONE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. THE POSSIBILITY THAT POOR SAMPLE PROCESSING, HAD CONTRIBUTED TO THE RESULTS COULD NOT BE RULED OUT. THE INVESTIGATION DETERMINED THAT THE SAMPLES IN QUESTION WERE NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE...

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A NON-REPEATABLE HIGHER THAN EXPECTED VITROS TROPI ES RESULT FROM ONE PATIENT SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULT WAS REPORTED OUTSIDE THE LABORATORY. A CORRECTED REPORT WAS ISSUED THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1