BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 2251734 · Received September 16, 2011

    Report

    Report Number
    3007111389-2011-00145
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 18, 2011
    Report Date
    September 16, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. IN ADDITION, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS WERE OBTAINED WHEN PROCESSING A TROPONIN FREE FLUID AS THE SAMPLE. AN OCD FIELD ENGINEER IS INVESTIGATING CURRENT PERFORMANCE OF THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. IT IS UNKNOWN IF THE SAMPLES IN QUESTION WERE 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. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING OR AN INSTRUMENT RELATED EVENT CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN, AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS (SAMPLE 1 = 0.410 NG/ML, SAMPLE 2 = 0.410 NG/ML) FROM MULTIPLE PATIENT SAMPLES 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 RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. EXPECTED RESULTS (SAMPLE 1 = 0.012 NG/ML, SAMPLE 2 = 0.012 NG/ML) WERE OBTAINED FOR THE PATIENT SAMPLES UPON REPEAT ANALYSIS. IN ADDITION, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS (0.200, 0.230 NG/ML) WERE OBTAINED WHEN PROCESSING A TROPONIN FREE FLUID (EXPECTED < 0.014 NG/ML) AS THE SAMPLE. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF FOUR MDR'S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 0720

    Patients

    Seq Age Sex Outcome Treatment
    1