BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 3081360 · Received April 26, 2013

    Report

    Report Number
    3007111389-2013-00097
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 26, 2013
    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, HIGHER THAN EXPECTED VITROS TROP I ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHILE USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE SAMPLE MAY NOT HAVE BEEN 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 COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. ADDITIONALLY, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE WAS NO EVIDENCE THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPEATABLE FALSELY ELEVATED TROPONIN I ES RESULT (PATIENT RESULT = 0.321 VS. EXPECTED RESULT= 0.007) FROM A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE FALSELY ELEVATED VITROS TROPI ES RESULT WAS REPORTED FROM THE LABORATORY. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. ONCE IDENTIFIED, A CORRECTED RESULT WAS ISSUED FOR THE PATIENT SAMPLE. THERE WAS NO ALLEGATION OF INAPPROPRIATE MEDICAL ACTION OR PATIENT HARM DUE TO THE FALSELY ELEVATED RESULT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180770 VITROS ECI IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS 1160

    Patients

    Seq Age Sex Outcome Treatment
    1