BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 3843963 · Received June 2, 2014

    Report

    Report Number
    3007111389-2014-00117
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROP I ES RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES PROCESSED ON A VITROS ECIQ IMMUNODIAGNOSTICS SYSTEM. A VITROS TROPI ES REAGENT AND AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. IN ADDITION, THE INVESTIGATION COULD NOT DETERMINE IF THE CUSTOMER HAD PROCESSED THE PATIENT SAMPLE IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THEREFORE, THE EFFECT OF IMPROPER SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. FINALLY, THE CUSTOMER WAS NOT PERFORMING THE RECOMMENDED DAILY AND WEEKLY ANALYZER MAINTENANCE, THEREFORE USER ERROR CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS FROM MULTIPLE PATIENT SAMPLES PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTICS SYSTEM. PATIENT 1 TROPI ES: 0.284 VS. EXPECTED 0.013 NG/ML; PATIENT 2TROPI ES: 0.093 VS. EXPECTED 0.012 NG/ML; PATIENT 3 TROPI ES: 0.103 VS. EXPECTED 0.012 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE NON-REPRODUCIBLE, FALSELY ELEVATED TROPI ES RESULTS WERE NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321570 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1400

    Patients

    Seq Age Sex Outcome Treatment
    1