BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCT TROPI ES REAGENT PACK

    MDR report key: 3904283 · Received July 1, 2014

    Report

    Report Number
    3007111389-2014-00143
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROPI ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER, SINCE A PRECISION RUN WAS NOT COMPLETED BEFORE THE ANALYZER WAS SERVICED, AN INSTRUMENT ISSUE CANNOT BE COMPLETELY RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO MULTIPLE ANALYZER SUBSYSTEMS TO RETURN THE ECIQ SYSTEM TO ITS EXPECTED PERFORMANCE. FOLLOWING THESE ACTION, ACCEPTABLE VITROS TROPI ES PRECISION WAS OBSERVED. THERE WAS NO INDICATION THAT A REAGENT ISSUE CONTRIBUTED TO THE EVENT. 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 ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. PATIENT TROPI ES= 0.912 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 RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384231 VITROS IMMUNODIAGNOSTIC PRODUCT TROPI ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1410

    Patients

    Seq Age Sex Outcome Treatment
    1