BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 3032327 · Received April 3, 2013

    Report

    Report Number
    1319681-2013-00078
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, VITROS TROP I ES QUALITY CONTROL RESULTS WERE OBTAINED FROM A KNOWN TROPONIN I FREE SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO RETURN THE SYSTEM TO EXPECTED PERFORMANCE. THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS ANALYZER RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, VITROS TROPI I ES RESULTS FOR A KNOWN TROPONIN I FREE SAMPLE (3.59, 0.061 VS. EXPECTED RESULTS < 0.014 NG/ML) PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO OCCUR ON PATIENT SAMPLES UNDETECTED. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED IN A WAY THAT COULD CAUSE PATIENT HARM. 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
    137251 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1