BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1958223 · Received January 12, 2011

    Report

    Report Number
    1319681-2011-00011
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 13, 2010
    Report Date
    February 11, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 ECIQ IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND THE INVESTIGATION IS ONGOING. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    INITIALLY, THE INVESTIGATION COULD NOT DETERMINE A ROOT CAUSE. AN OCD NATIONAL FIELD SPECIALIST (NFS) VISITED THE CUSTOMER SITE AND REPLACED A LOOSE SCREW IN THE INCUBATOR WELL SHUTTLE SUSPECTED OF CAUSING ERRATIC WELL MOVEMENT. FOLLOWING THIS ACTIVITY, ACCEPTABLE VITROS TROPI ES PERFORMANCE WAS OBSERVED. THE NFS ALSO DETERMINED THAT SAMPLE FLUID WAS SPLASHING ONTO THE SAMPLE TRAYS WHEN THE TRAYS WERE REMOVED BY THE SYSTEM OPERATOR, WHICH MAY HAVE CONTAMINATED THE VERSATIPS USED FOR SAMPLE PROCESSING. THE CUSTOMER IMPLEMENTED A SAMPLE TRAY HANDLING PROCEDURE TO ADDRESS THIS ISSUE. THE MOST LIKELY CAUSE OF THIS EVENT WAS DETERMINED TO BE AN INSTRUMENT ISSUE IN COMBINATION WITH PRE-ANALYTICAL OPERATIONAL ISSUES RESULTING IN SAMPLE CONTAMINATION OF THE UNIVERSAL SAMPLE TRAYS AND VERSATIPS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS FROM MULTIPLE PATIENT SAMPLES PROCESSED ON THE VITROS ECIQ 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. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1