BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 5301868 · Received December 16, 2015

    Report

    Report Number
    3007111389-2015-00399
    Event Type
    Malfunction
    Date Received
    December 16, 2015
    Date of Event
    November 19, 2015
    Report Date
    December 16, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS DETERMINED THAT A RETROSPECTIVE REVIEW OF ECONNECTIVITY DATA FOR AN INTERNAL ORTHO CLINICAL DIAGNOSTIC INVESTIGATION FOUND A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPONIN I ES RESULTS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS TROPONIN I ES REAGENT ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE, HOWEVER THE POSSIBILITY THAT AN UNEXPECTED VITROS TROPONIN I ES REAGENT PERFORMANCE OR AN UNEXPECTED VITROS ECI IMMUNODIAGNOSTIC SYSTEM PERFORMANCE HAD CONTRIBUTED TO THE RESULT COULD NOT BE RULED OUT ENTIRELY.

    Description of Event or Problem · 1

    A RETROSPECTIVE REVIEW OF ECONNECTIVITY DATA FOR AN INTERNAL ORTHO CLINICAL DIAGNOSTIC INVESTIGATION FOUND A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPONIN I ES RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE (TROPONIN I = 0.069 NG/ML VERSUS A DUPLICATE RESULT OF 0.014 NG/ML), USING VITROS TROPONIN I ES REAGENT ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. IT IS UNKNOWN IF THE RESULT WAS REPORTED TO A CLINICIAN BUT IT IS ASSUMED THAT THE UNEXPECTED RESULT WOULD HAVE BEEN CAPTURED BY THE FACILITY'S DELTA CHECK. SINCE THE CUSTOMER DID NOT REPORT THE EVENT DIRECTLY TO ORTHO CLINICAL DIAGNOSTICS, IT IS ASSUMED THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832117 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 2000

    Patients

    Seq Age Sex Outcome Treatment
    1