BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1797615 · Received August 12, 2010

    Report

    Report Number
    1319681-2010-00162
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 14, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT NON-REPRODUCIBLE FALSELY ELEVATED TROP I ES RESULTS OCCURRED WHEN SAMPLES WERE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION IS ON-GOING AND HAS NOT DETERMINED ROOT CAUSE. THE ROOT CAUSE OF THE EVENT IS UNKNOWN; HOWEVER, THE PERFORMANCE OF THE VITROS 5600 INTEGRATED SYSTEM IS STILL BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE OCD FIELD ENGINEER OBTAINED A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULT WHILE PERFORMING A TROP I ES PRECISION TEST ON THE VITROS 5600 INTEGRATED SYSTEM. SUBSEQUENTLY, A NON-REPRODUCIBLE HIGHER THAN EXPECTED PATIENT VITROS TROP I ES RESULT OCCURRED ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO INDICATION THAT THE AFFECTED PATIENT SAMPLE WAS REPORTED TO THE CLINICIAN AS THE CUSTOMER WAS RUNNING THE TROP I ES ASSAY IN DUPLICATE WHEN THE AFFECTED RESULT OCCURRED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1