BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2970113 · Received February 20, 2013

    Report

    Report Number
    1319681-2013-00050
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROPI I ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO MULTIPLE SUBSYSTEMS OF THE ANALYZER. FOLLOWING THESE SERVICE ACTIONS, ACCEPTABLE TROP I ES PERFORMANCE WAS OBTAINED. ADDITIONALLY, THE SAMPLE 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. THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS ANALYZER RELATED. HOWEVER, 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 TROPI I ES RESULT (0.1 VS. EXPECTED RESULTS < 0.012 NG/ML) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE AFFECTED RESULT WAS REPORTED OUT OF THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE PHYSICIAN QUESTIONED THE AFFECTED RESULT AND THE SAMPLE WAS RETESTED. A CORRECTED REPORT WAS ISSUED. 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
    73910 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNOASSAY SYSTEM KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1