BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1356011 · Received February 12, 2009

    Report

    Report Number
    1319681-2009-00031
    Event Type
    Malfunction
    Date Received
    February 12, 2009
    Date of Event
    January 15, 2009
    Report Date
    January 15, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS FIRST SAMPLE EVENT HAS DETERMINED THAT THE ROOT CAUSE WAS INSTRUMENT RELATED. A LUMINOMETER SIGNAL PROCESSOR BOARD WAS REPLACED AND THE INSTRUMENT WAS RETURNED TO WORKING ORDER. THE EVENT TOOK PLACE DURING AN INSTRUMENT CROSSOVER ASSESSMENT AND PATIENT RESULTS WERE NOT BEING REPORTED AT THE TIME.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED FALSE NEGATIVE RESULTS ON A QUALITY CONTROL FLUID (ASSAYED 2009) USING VITROS IMMUNODIAGNOSTICS PRODUCT ANTI-HBC IGM REAGENT ON THE VITROS ECIQ SYSTEM. AN ALTERNATE VITROS ECIQ SYSTEM REPORTED POSITIVE RESULTS WHICH WERE CONSISTENT WITH THE QUALITY CONTROL FLUID ASSIGNED VALUE. NO PATIENT RESULT WAS REPORTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1