BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1962252 · Received January 18, 2011

    Report

    Report Number
    1319681-2011-00015
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 18, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PSA AND VITROS TSH QUALITY CONTROL RESULTS WERE OBTAINED FROM THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. AN OCD FIELD ENGINEER PERFORMED MAINTENANCE ON THE MICROWELL INCUBATOR AND SIGNAL REAGENT SUBSYSTEMS TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. THE ROOT CAUSE OF THIS EVENT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED IMPRECISE VITROS PSA AND VITROS TSH QUALITY CONTROL RESULTS WHILE USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. PATIENT SAMPLES WERE NOT TESTED DURING THE INTERVAL THAT THE IMPRECISE QUALITY CONTROL RESULTS WERE OBTAINED. 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
    1 VITROS ECI IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1