BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT

    MDR report key: 2113225 · Received June 3, 2011

    Report

    Report Number
    3007111389-2011-00066
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 ECI IMMUNODIAGNOSTIC SYSTEM. THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE INVESTIGATION DETERMINED THE MOST LIKELY ASSIGNABLE CAUSE OF THIS RESULT WAS INSTRUMENT RELATED. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO MULTIPLE ANALYZER SUBSYSTEMS TO RETURN THE ECI SYSTEM TO EXPECTED PERFORMANCE. FOLLOWING THESE ACTION, ACCEPTABLE VITROS TROPI ES PRECISION WAS OBSERVED. DURING THE MONITORING PERIOD, ADDITIONAL NON-REPRODUCIBLE, FALSELY ELEVATED, TROP I ES RESULTS OCCURRED ON MULTIPLE PATIENT SAMPLES PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED, HOWEVER, THE POSSIBILITY OF AN ANALYZER MALFUNCTION AND THE EFFECT OF SAMPLE PROCESSING COULD NOT BE RULED OUT AS POTENTIAL ROOT CAUSES. THE INVESTIGATION DETERMINED THAT THE CUSTOMER HAD PROCESSED THE PATIENT SAMPLES OUTSIDE THE SAMPLE COLLECTION TUBE MANUFACTURER'S RECOMMENDATIONS FOR CENTRIFUGATION TIME AND SPEED. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. IN ADDITION, A TROPI ES PRECISION TEST WAS NOT PERFORMED; THEREFORE, IT IS NOT POSSIBLE TO RULE OUT THAT AN ANALYZER RELATED ISSUE MAY HAVE CONTRIBUTED TO THE EVENT. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO MULTIPLE ANALYZER SUBSYSTEMS TO RETURN THE ECI SYSTEM TO EXPECTED PERFORMANCE. FOLLOWING THESE ACTION, ACCEPTABLE VITROS TROPI ES PRECISION WAS OBSERVED.

    Description of Event or Problem · 1

    DURING A COMPLAINT INVESTIGATION, THE CUSTOMER OBTAINED NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROPI ES RESULTS ON MULTIPLE PATIENTS, USING A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. INITIALLY, THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROPI ES RESULT (0.109 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 (REPEAT 0.020 NG/ML) WAS BELIEVED TO BE THE ACCURATE RESULT. THE HIGHER THAN EXPECTED PATIENT RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. SUBSEQUENTLY, THE CUSTOMER OBSERVED NON-REPRODUCIBLE, FALSELY ELEVATED, VITROS TROPI ES RESULTS FROM MULTIPLE PATIENT SAMPLES. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THESE SAMPLES WERE RETESTED AND THE REPEAT RESULTS WERE EXPECTED, BASED ON THE PATIENT'S CLINICAL PRESENTATION. THE INITIAL, NON-REPRODUCIBLE, FALSELY ELEVATED, VITROS TROPI ES RESULTS AND THE REPEAT RESULTS WERE NOT PROVIDED BY THE CUSTOMER. 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. IN ADDITION, THE CUSTOMER OBTAINED IMPRECISE, VITROS TROPI ES RESULTS FROM A SINGLE PATIENT SAMPLE (0.114, 0.174 NG/ML) PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE 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. THIS REPORT IS NUMBER TWO OF SIX 3500A FORMS FILED FOR THIS EVENT, AS MULTIPLE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 0640

    Patients

    Seq Age Sex Outcome Treatment
    1