BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1813549 · Received August 25, 2010

    Report

    Report Number
    1319681-2010-00171
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE FALSELY ELEVATED VITROS TROP I ES RESULTS OCCURRED FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION DETERMINED THE VITROS 5600 SYSTEM WAS OPERATING AS INTENDED AND NO MALFUNCTION WAS IDENTIFIED. IT IS POSSIBLE THE SAMPLES WERE NOT PROCESSED AS RECOMMENDED BY THE SAMPLE COLLECTION DEVICE MANUFACTURE, BUT THIS COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED, HOWEVER PRE-ANALYTICAL SAMPLE PROCESSING AS A POSSIBLE CONTRIBUTOR CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NON-REPEATABLE HIGHER THAN EXPECTED VITROS TROPI ES RESULTS FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE HIGHER THAN EXPECTED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. CORRECTED RESULTS WERE ISSUED AND 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 CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1