BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 3734646 · Received April 8, 2014

    Report

    Report Number
    3007111389-2014-00067
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 8, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROPI ES RESULTS WERE OBTAINED FROM TWO PATIENT SAMPLES AND A TROPONIN I-FREE SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED. A VITROS TROPI ES REAGENT OR AN INSTRUMENT ISSUE, AS WELL AS AMBIENT CONDITIONS OR IMPROPER SAMPLE HANDLING PROTOCOL CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. IN ADDITION, THE INVESTIGATION COULD NOT DETERMINE IF THE CUSTOMER HAD PROCESSED THE PATIENT SAMPLES IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. THEREFORE, THE EFFECT OF IMPROPER SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE DEFINITIVE ASSIGNABLE CAUSE FOR THE EVENT IS UNKNOWN. INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS TROPI ES RESULTS OBTAINED FROM TWO PATIENT SAMPLES AND A TROPONIN I-FREE SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. VITROS TROPONIN I-FREE SAMPLE: 0.069, 0.106 NG/ML VERSUS EXPECTED <0.012 NG/ML. PATIENT 1 TROPI ES: 0.225, 0.115 NG/ML, VERSUS EXPECTED ¿NEGATIVE¿ TROPONIN I RESULT FROM A NON-VITROS VIDAS INSTRUMENT. PATIENT 2 TROPI ES: 0.062 NG/ML, VERSUS EXPECTED: 0.029 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE NOT REPORTED FROM THE LABORATORY AS ALL SAMPLES WITH A TROPI ES RESULT GREATER THAN 0.034 NG/ML ARE VERIFIED PRIOR TO REPORTING. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER ONE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210644 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1420

    Patients

    Seq Age Sex Outcome Treatment
    1