BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2181979 · Received July 28, 2011

    Report

    Report Number
    1319681-2011-00150
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 25, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES PROCESSED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. PRIOR TO SERVICE, A TROPONIN I PRECISION TEST WAS OUTSIDE OF ACCEPTABLE GUIDELINES. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO MULTIPLE ANALYZER SUBSYSTEMS TO RETURN THE ECIQ SYSTEM TO EXPECTED PERFORMANCE. FOLLOWING THESE ACTIONS, ACCEPTABLE VITROS TROPI ES PRECISION WAS OBSERVED. IN ADDITION, THE INVESTIGATION DETERMINED IN ADDITION, THE INVESTIGATION DETERMINED THE CUSTOMER HAD PROCESSED THE PATIENT SAMPLES OUTSIDE THE SAMPLE COLLECTION TUBE MANUFACTURER'S RECOMMENDATIONS FOR CENTRIFUGATION TIME AND SPEED. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THEREFORE, THE EFFECT OF IMPROPER SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS RESULT WAS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROPI ES RESULTS ON MULTIPLE PATIENTS, USING A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROPI ES RESULTS (0.118 AND 0.175 NG/ML) FROM A SINGLE PATIENT SAMPLE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE SAME SAMPLE WAS RETESTED AND THE REPEAT RESULT (<0.012 NG/ML) WAS BELIEVED TO BE THE ACCURATE RESULT. THE HIGHER THAN EXPECTED PATIENT RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. DURING THE INVESTIGATION, ADDITIONAL NON-REPRODUCIBLE, FALSELY ELEVATED, VITROS TROPI ES RESULTS FROM 9 SEPARATE PATIENT SAMPLES WERE OBSERVED. THE INITIAL AND REPEAT TROPI ES RESULTS FOR THOSE SAMPLES ARE: SAMPLE 2 0.100 NG/ML VS. 0.027 NG/ML, SAMPLES 3 THROUGH 9 YIELDED 0.80, 0.110, 0.100, 0.07, 0.080, 0.130, 0.086 NG/ML VS REPEAT RESULTS <0.012 NG/ML. SAMPLE 10 HAD AN INITIAL RESULT OF 0.070 NG/ML VS 0.026 NG NG/ML. ADDITIONALLY, DURING THE INVESTIGATION A RESULT OF 0.077 NG/ML VS EXPECTED <0.014 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE REPEAT RESULTS WERE BELIEVED TO BE THE ACCURATE TROPI ES RESULTS FOR THE PATIENTS. THE NON-REPRODUCIBLE, FALSELY ELEVATED TROPI ES RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO REPORTED 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 IMMUNOASSAY SYSTEM MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1