BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2142083 · Received June 28, 2011

    Report

    Report Number
    1319681-2011-00139
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. EVALUATION OF THE SYSTEM DEMONSTRATED UNACCEPTABLE VITROS TROP I ES PRECISION. AN OCD FIELD ENGINEER PERFORMED MULTIPLE SERVICE ACTIONS INCLUDING REPLACEMENT OF THE MICROWELL INCUBATOR. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A REAGENT MALFUNCTION HAD OCCURRED. THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS INSTRUMENT RELATED, AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULT (0.195 NG/ML) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE HIGHER THAN EXPECTED RESULT WAS NOT REPORTED OUT OF THE LABORATORY, AS A VITROS TROP I ES RESULT OF < 0.012 NG/ML WAS OBTAINED UPON REPEAT ANALYSIS. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (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