BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 2685692 · Received August 7, 2012

    Report

    Report Number
    3007111389-2012-00133
    Event Type
    Malfunction
    Date Received
    August 7, 2012
    Date of Event
    July 7, 2012
    Report Date
    August 7, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS WERE OBTAINED FOR FOUR PATIENT SAMPLES FROM FOUR DIFFERENT PATIENTS. THE INVESTIGATION DETERMINED THAT THE SAMPLES INVOLVED WERE NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATION. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO MULTIPLE ANALYZER SUBSYSTEMS. HOWEVER, IT COULD NOT BE CONFIRMED THAT THE EQUIPMENT ADJUSTMENTS MADE BY THE SERVICE ENGINEER WERE RELATED TO THE EVENT, AS ACCEPTABLE PERFORMANCE WAS OBTAINED PRIOR TO SERVICE. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, IMPROPER PRE-ANALYTICAL SAMPLE PROCESSING AND/OR A REAGENT RELATED ISSUE CANNOT BE RULED OUT AS POSSIBLE CONTRIBUTING FACTORS. THERE IS NO EVIDENCE THAT THE VITROS ECI ANALYZER HAD MALFUNCTIONED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS FOR FOUR PATIENT SAMPLES FROM FOUR DIFFERENT PATIENTS (PATIENT 1 RESULT = 0.077 NG/ML; PATIENT 2 RESULT = 0.115 NG/ML; PATIENT 3 RESULT = 0.249 NG/ML; PATIENT 4 RESULT = 1.94 NG/ML) WHILE USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED TROP I ES RESULTS WERE NOT REPORTED TO A CLINICIAN, AS THE CUSTOMER RUNS TROP I ES PATIENT SAMPLES IN DUPLICATE (REPEAT PATIENT 1 RESULT = 0.001 NG/ML; REPEAT PATIENT 2 RESULT = 0.015 NG/ML; REPEAT PATIENT 3 RESULT = 0.004 NG/ML; REPEAT PATIENT 4 RESULT = 0.001 NG/ML), AND BELIEVED THE REPEAT RESULTS TO BE CORRECT. THERE WAS NO REPORT OF HARM TO THE PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF FOUR MDR¿S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC. COMPLAINT NUMBERS 31717956, 31719255, AND 31720838 / IVD 251239.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 0890

    Patients

    Seq Age Sex Outcome Treatment
    1