BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 2863822 · Received December 10, 2012

    Report

    Report Number
    3007111389-2012-00246
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT TWO NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES RUN ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THERE WAS NO EVIDENCE TO SUGGEST A REAGENT MALFUNCTION HAD OCCURRED. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO SEVERAL SUBSYSTEMS OF THE ANALYZER. FOLLOWING THESE ACTIONS, ACCEPTABLE VITROS TROP I ES PERFORMANCE WAS OBSERVED. ADDITIONALLY, 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. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE AND/OR POOR ANALYZER PERFORMANCE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS (PATIENT 1=0.238 AND PATIENT 2= 0.468 VS. EXPECTED RESULTS <0.012 NG/ML) FROM TWO DIFFERENT PATIENT SAMPLES RUN ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE CUSTOMER RETESTED THE AFFECTED PATIENT SAMPLES PER CUSTOMER POLICY PRIOR TO REPORTING. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1030

    Patients

    Seq Age Sex Outcome Treatment
    1