BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 3895181 · Received June 25, 2014

    Report

    Report Number
    1319681-2014-00112
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    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 TROPONIN I ES RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHILE USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THERE WAS NO INDICATION THAT A REAGENT ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION DETERMINED THE SAMPLE WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER¿S RECOMMENDATIONS. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE ASSIGNABLE CAUSE FOR THE PATIENTS AND THE TROPONIN I FREE SAMPLE IS AN INSTRUMENT RELATED ISSUE. ADDITIONALLY, A PRE-ANALYTICAL SAMPLE HANDLING AND AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I ES RESULTS FROM MULTIPLE PATIENT SAMPLES PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. PATIENT 1= 0.087 VS. EXPECTED <0.012. PATIENT 2= 0.167 VS. EXPECTED <0.01. PATIENT 3= 0.105 VS. EXPECTED <0.01. PATIENT 4= 0.272 VS. EXPECTED <0.01. PATIENT 5= 0.060 VS. EXPECTED <0.01. PATIENT 6= 0.118 VS. EXPECTED <0.01. PATIENT 7= 0.200 VS. EXPECTED <0.01. PATIENT 8= 0.088 VS. EXPECTED <0.01. PATIENT 9= 0.216 VS. EXPECTED <0.01. TROPONIN I FREE SAMPLE= 0.069 VS. EXPECTED <0.012. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RECUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS TROPI ES RESULT OF 0.087 NG/ML ON PATIENT 1 WAS REPORTED OUTSIDE OF THE LABORATORY AND THE PATIENT WAS TREATED WITH LOVENOX, FLAVIX AND ASPIRIN. IT WAS RECORDED IN THE PATIENT 1 FILE THAT THE TROPI ES 0.087 NG/ML RESULT WAS A FALSE POSITIVE. THE PATIENT 2 HIGHER THAN EXPECTED VITROS TROPI ES RESULT OF 0.167 NG/ML WAS REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN AFTER REPEAT TESTING WAS COMPLETE. THE HIGHER THAN EXPECTED VITROS TROPI ES RESULTS ON PATIENTS 3-9 WERE NOT REPORTED OUT OF THE LABORATORY. THERE IS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371879 VITROS ECI IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC SYSTEM KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1