BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2933618 · Received January 29, 2013

    Report

    Report Number
    1319681-2013-00038
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 29, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A CUSTOMER OBTAINED POSITIVE VITROS AHBS RESULTS ON TWO DIFFERENT PATIENT SAMPLES THA LATER TESTED NEGATIVE WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THERE WAS NO EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO THE WELL WASH SUBSYSTEM OF THE ANALYZER. FOLLOWING THESE SERVICE ACTIONS, ACCEPTABLE PERFORMANCE OF THE VITROS ECIQ SYSTEM WAS OBTAINED. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE MOST LIKELY ROOT CAUSE WAS FOUND TO BE ANALYZER RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED POSITIVE VITROS AHBS RESULTS (PATIENT A = 71.6,POSITIVE PATEINT B = 105,POSITIVE VS. EXPECTED RESULTS = 0.0 MIU/L, NEGATIVE ) ON TWO DIFFERENT PATIENT SAMPLES WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE AFFECTED RESULTS WERE REPORTED OUT OF THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE DISCORDANT RESULTS WERE DISCOVERED WHEN THE AFFECTED SAMPLES WERE UNINTENTIONALLY REPEAT TESTED. CORRECTED REPORTS WERE 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
    38664 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1