BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT

    MDR report key: 2041352 · Received April 6, 2011

    Report

    Report Number
    3007111389-2011-00027
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE FALSELY ELEVATED TROP I ES RESULTS OCCURRED ON A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, USER ERROR IN USING IMPROPER PRE-ANALYTICAL SAMPLE HANDLING (CENTRIFUGATION) MAY HAVE CONTRIBUTED TO THE EVENT. THE SAMPLE IN QUESTION WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THERE WAS NO INDICATION THE ECI ANALYZER WAS NOT PERFORMING AS INTENDED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROP I ES RESULT FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE HIGHER THAN EXPECTED PATIENT RESULT WAS REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, A CORRECTED REPORT WAS SENT TO THE PHYSICIAN, AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 0600

    Patients

    Seq Age Sex Outcome Treatment
    1