BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2862112 · Received December 7, 2012

    Report

    Report Number
    1319681-2012-00236
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 6, 2012
    Report Date
    December 6, 2012
    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 CONFIRMED THAT MULTIPLE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS OCCURRED WHILE USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THERE IS NO EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO THE INCUBATOR RING AND THE REAGENT METERING SUBSYSTEM OF THE ANALYZER. FOLLOWING THESE ACTIONS, ACCEPTABLE VITROS TROP I ES PERFORMANCE HAS BEEN OBSERVED. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY ROOT CAUSE IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS FROM MULTIPLE PATIENT SAMPLES PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. PATIENT 2: 0.128 VS. AN EXPECTED RESULT = 0.012 G/ML; PATIENT 3: 0.102, 0.083 VS. AN EXPECTED RESULT = 0.012 G/ML; PATIENT 4: 0.120 VS. AN EXPECTED RESULT = 0.012 G/ML; PATIENT 7: 0.057 VS. AN EXPECTED RESULT = 0.012 G/ML; CUSTOMER POLICY IS TO PERFORM VITROS TROP I PATIENT SAMPLE REPEAT TESTING. HOWEVER, THE HIGHER THAN EXPECTED PATIENT 3 RESULT (0.102 G/ML) WAS REPORTED FROM THE LABORATORY PRIOR TO REPEAT TESTING. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. PATIENT 3 WAS ADMINISTERED HEPARIN BASED ON THE AFFECTED RESULT. A CORRECTED REPORT WAS ISSUED FOR PATIENT 3. THERE WAS NO ALLEGATION 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