BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 2870890 · Received December 12, 2012

    Report

    Report Number
    3007111389-2012-00253
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 7, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULT WAS OBTAINED FROM A SINGLE PATIENT RUN ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO OPTIMIZE SYSTEM PERFORMANCE. FOLLOWING THESE ACTIONS, ACCEPTABLE VITROS TROP I ES PERFORMANCE WAS OBSERVED. ADDITIONALLY, IT IS UNKNOWN IF THE SAMPLE IN QUESTION WAS 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 SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, AN INSTRUMENT AND/OR A REAGENT RELATED ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS AT THIS TIME. ADDITIONALLY, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULT (0.060 VS. EXPECTED RESULT = 0.015 NG/ML) FROM A SINGLE PATIENT RUN ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE AFFECTED RESULT WAS NOT REPORTED OUT OF THE LABORATORY AS THE CUSTOMER PERFORMED ALL VITROS TROP I ES TESTING IN DUPLICATE. THERE WAS NO ALLEGATION 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 1040

    Patients

    Seq Age Sex Outcome Treatment
    1