BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 3863807 · Received June 10, 2014

    Report

    Report Number
    1319681-2014-00105
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROPI ES RESULTS WERE OBTAINED FROM TWO PATIENT SAMPLES AND A TROPONIN I-FREE SAMPLE WHEN USING A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT WAS INSTRUMENT RELATED, AS MULTIPLE PRECISION TESTS WERE OUTSIDE OF OCD ACCEPTABLE GUIDELINES. AN OCD FIELD ENGINEER PERFORMED MAINTENANCE AND SERVICE ACTIONS TO RETURN THE ECI SYSTEM TO ITS EXPECTED PERFORMANCE. FOLLOWING THESE ACTION, ACCEPTABLE VITROS TROPI ES PRECISION WAS OBSERVED. A REAGENT ISSUE CANNOT BE RULED OUT, AS THE HISTORICAL QUALITY CONTROL REVIEW SHOWED ELEVATED PRECISION AT THE LOW LEVEL CONTROL. FINALLY, THE INVESTIGATION DETERMINED THE SAMPLES WERE NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER¿S RECOMMENDATIONS. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT WAS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES AND A VITROS HIGH SAMPLE DILUENT B (TROPONIN I-FREE) SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. PATIENT 1 TROPI ES= 0.21 NG/ML VERSUS EXPECTED 0. 020 NG/ML PATIENT 2 TROPI ES= 0.14 NG/ML VERSUS EXPECTED <0.012 NG/ML TROPONIN I FREE SAMPLE= 0.084 NG/ML VERSUS EXPECTED <0.012 NG/ML BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339156 VITROS ECI IMMUNODIAGNOSTIC SYSTEM IMMNOASSAY SYSTEM KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1