BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 3892390 · Received June 24, 2014

    Report

    Report Number
    3007111389-2014-00136
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE NON-REPRODUCIBLE, FALSELY ELEVATED TROPONIN I ES RESULTS WERE OBTAINED FROM THREE PATIENT SAMPLES WHILE USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE. BASED ON INFORMATION AVAILABLE, A DUSTY LABORATORY ENVIRONMENT OR AN UNEXPECTED VITROS HIGH SAMPLE DILUENT B FLUID ISSUE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THERE WAS NO EVIDENCE TO SUGGEST THAT THE VITROS INSTRUMENT AND REAGENT CONTRIBUTED TO THE EVENT. 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 WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED SEVERAL NON-REPRODUCIBLE, FALSELY ELEVATED TROPONIN I ES RESULTS FROM FOUR SAMPLES DRAWN FROM THREE DIFFERENT PATIENTS WHEN PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. PATIENT 1: TROPI ES= 0.268 AND 0.088 VS. EXPECTED <0.012 NG/ML. PATIENT 2: TROPI ES= 0.194 VS. EXPECTED <0.012 NG/ML. PATIENT 3: TROPI ES= 5.61 VS. EXPECTED <0.012 NG/ML BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE NON-REPRODUCIBLE, FALSELY ELEVATED TROPI ES RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER ONE OF FOUR MDR¿S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367887 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1450

    Patients

    Seq Age Sex Outcome Treatment
    1