BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 2964308 · Received February 15, 2013

    Report

    Report Number
    3007111389-2013-00045
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES PATIENT RESULTS WERE OBTAINED FROM TWO SERIAL SAMPLES OF A SINGLE PATIENT WHILE USING THE VITROS ECI SYSTEM. THERE IS NO EVIDENCE TO SUGGEST THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. AN OCD FILED ENGINEER PERFORMED SERVICE ACTIONS TO THE LIFT PIN MOTOR TO OBTAIN ACCEPTABLE PERFORMANCE. ADDITIONALLY, THE SAMPLE WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE OR AN ANALYZER RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS (SERIAL SAMPLE 1 RESULT = 0.077, SERIAL SAMPLE 2 RESULT = 0.169 VS. AN EXPECTED RESULT < 0.012 NG/ML ) FROM TWO SERIAL SAMPLES OF A SINGLE PATIENT PROCESSED ON THE VITROS ECI SYSTEM. THE AFFECTED RESULT FROM SERIAL SAMPLE 1 WAS REPORTED. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. NO TREATMENT WAS GIVEN, CHANGED, OR WITHHELD BASED ON THE AFFECTED RESULT FOR SERIAL SAMPLE 1. THE AFFECTED SERIAL SAMPLE 2 RESULT WAS NOT REPORTED. THE AFFECTED SAMPLES WERE IDENTIFIED WHEN PATIENT SERIAL SAMPLE RESULTS WERE COMPARED WITH THE DELTA CHECK PROCESS. 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
    68433 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1080

    Patients

    Seq Age Sex Outcome Treatment
    1