BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2191558 · Received August 4, 2011

    Report

    Report Number
    1319681-2011-00158
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS TROPI ES RESULT WAS OBTAINED ON A KNOWN TROPONIN I FREE SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION DETERMINED THE MOST LIKELY ASSIGNABLE CAUSE OF THIS RESULT WAS INSTRUMENT RELATED. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO MULTIPLE ANALYZER SUBSYSTEMS TO RETURN THE 5600 SYSTEM TO EXPECTED PERFORMANCE. FOLLOWING THESE ACTION, ACCEPTABLE VITROS TROPI ES PRECISION WAS OBSERVED.

    Description of Event or Problem · 1

    DURING A COMPLAINT INVESTIGATION, THE CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS TROPI ES RESULT (0.091 NG/ML) ON A KNOWN TROPONIN I FREE SAMPLE, DURING A TROPI ES PRECISION TEST, USING A VITROS 5600 INTEGRATED SYSTEM. THE EXPECTED TROPI ES RESULT ON THE TROPONIN I FREE SAMPLE IS <0.014 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. PATIENT SAMPLES WERE NOT PROCESSED WHILE THE PRECISION TEST WAS OUTSIDE OF THE PRECISION GUIDELINE FOR TROPI ES AND 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 CHEMISTRY ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1