BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1910700 · Received November 30, 2010

    Report

    Report Number
    1319681-2010-00261
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT FALSE NEGATIVE VITROS AHBC RESULTS WERE OBTAINED FROM AN ANTI-HBC POSITIVE QUALITY CONTROL FLUID USING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. NO MALFUNCTION OF THE VITROS AHBC REAGENT OR VITROS ECIQ SYSTEM WAS IDENTIFIED. PRE-ANALYTICAL SAMPLE MIX-UP COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR. THE INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    FALSE NEGATIVE VITROS ANTI-HBC (AHBC) RESULTS WERE OBTAINED FROM AN ANTI-HBC POSITIVE QUALITY CONTROL FLUID USING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT SAMPLES WERE TESTED, AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1