BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2221799 · Received August 24, 2011

    Report

    Report Number
    1319681-2011-00167
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT HIGHER THAN EXPECTED, VITROS TSH QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS ECIQ SYSTEM. INVESTIGATION CONCLUDED AN INSTRUMENT ISSUE WAS THE MOST LIKELY ASSIGNABLE CAUSE. VITROS TSH PRECISION TESTING WAS PERFORMED WHICH DEMONSTRATED THE VITROS ECIQ SYSTEM WAS NOT PERFORMING OPTIMALLY. AN OCD FIELD ENGINEER PERFORMED SERVICE TO THE REAGENT METERING AND WELL WASH MODULES TO OPTIMIZE THE SYSTEM'S PERFORMANCE. FOLLOWING THESE ACTIONS, THE SYSTEM PERFORMANCE WAS VERIFIED BY PERFORMING A VITROS TSH PRECISION TEST.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A HIGHER THAN EXPECTED, VITROS TSH RESULTS FROM A QUALITY CONTROL SAMPLE WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC ANALYZER. HIGHER THAN EXPECTED RESULTS OF 0.132, 0.286, 0.159, 0.179 AND 0.153 MIU/L WERE OBTAINED FROM A LOW LEVEL TSH QUALITY CONTROL FLUID VS. AN EXPECTED MEAN VALUE OF 0.064 MIU/L. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE OBTAINED OR REPORTED FROM THE LABORATORY AS NO PATIENT SAMPLE TESTING WAS PERFORMED WHEN UNACCEPTABLE QUALITY CONTROL RESULTS WERE OBTAINED. HOWEVER, A BIASED PATIENT SAMPLE RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF NOT DETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC COMPLAINT NUMBER (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1