BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

    MDR report key: 5086853 · Received September 18, 2015

    Report

    Report Number
    3007111389-2015-00304
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    August 22, 2015
    Report Date
    September 18, 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 ONE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULT OBTAINED FROM ONE PATIENT SAMPLE USING VITROS TROPI ES REAGENT ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. ROOT CAUSE FOR THE UNEXPECTED RESULT 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. THE INVESTIGATION IS ONGOING INTO THE PERFORMANCES OF VITROS TROPONIN I ES KIT LOTS >=1710.

    Description of Event or Problem · 1

    A RETROSPECTIVE REVIEW OF ECONNECTIVITY DATA FOR AN INTERNAL ORTHO CLINICAL DIAGNOSTIC INVESTIGATION FOUND ONE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULT OBTAINED FROM ONE PATIENT SAMPLE USING VITROS TROPI ES REAGENT ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. VITROS TROPI ES RESULT: 0.110 NG/ML VS EXPECTED 0.020 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. IT IS UNKNOWN IF THE RESULT WAS REPORTED TO A CLINICIAN. IT IS ASSUMED THAT THE UNEXPECTED RESULT WOULD HAVE BEEN CAPTURED BY THE FACILITY'S DELTA CHECK. SINCE THE CUSTOMER DID NOT REPORT THIS RESULT DIRECTLY TO ORTHO CLINICAL DIAGNOSTICS, IT IS ASSUMED THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619931 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK IN-VITROS DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1870

    Patients

    Seq Age Sex Outcome Treatment
    1