BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 3870236 · Received June 12, 2014

    Report

    Report Number
    1319681-2014-00107
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED VITROS TEST RESULTS OBTAINED FROM THREE PATIENT SAMPLES USING A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM WERE NOT THE SAME VITROS TESTS ORDERED FOR EACH PATIENT BY THE LABORATORY INFORMATION SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE CAUSE. HOWEVER, AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT VITROS TEST RESULTS OBTAINED FROM THREE PATIENT SAMPLES USING A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM WERE NOT THE SAME VITROS TESTS ORDERED FOR EACH PATIENT BY THE LABORATORY INFORMATION SYSTEM. MIS-ASSOCIATED PATIENT RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT THAT UNINTENDED TEST RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. 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
    347658 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC SYSTEM KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1