BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 2339412 · Received November 16, 2011

    Report

    Report Number
    3007111389-2011-00215
    Event Type
    Malfunction
    Date Received
    November 16, 2011
    Date of Event
    October 26, 2011
    Report Date
    November 16, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS WERE OBTAINED FOR MULTIPLE PATIENT SAMPLES. THE SAMPLES INVOLVED MAY NOT HAVE BEEN PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATION. IT IS POSSIBLE 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 "AS NEEDED" MAINTENANCE TO THE REAGENT METERING, SIGNAL REAGENT METERING, WELL WASH, AND INCUBATOR SUBSYSTEMS ON THE VITROS ECIQ ANALYZER. HOWEVER, PERFORMANCE TESTING BEFORE AND AFTER SERVICE DEMONSTRATED ACCEPTABLE PERFORMANCE. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HOWEVER, IMPROPER PRE-ANALYTICAL SAMPLE PROCESSING AND/OR AN EQUIPMENT RELATED ISSUE CANNOT BE RULED OUT AS POSSIBLE CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS FOR MULTIPLE PATIENT SAMPLES (PATIENT 1 = 1.310 NG/ML; PATIENT 2 = 0.844 NG/ML) PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER REPEATED THE SAMPLES FOR THE AFFECTED PATIENTS (REPEAT OF PATIENT 1 IS < 0.012 NG/ML; REPEAT OF PATIENT 2 IS < 0.012 NG/ML). THE AFFECTED PATIENT RESULTS WERE NOT REPORTED TO THE CLINICIAN. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    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 0720

    Patients

    Seq Age Sex Outcome Treatment
    1