BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT PACK

    MDR report key: 4824960 · Received June 8, 2015

    Report

    Report Number
    3007111389-2015-00142
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 8, 2015
    Report Date
    June 8, 2015
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS DETERMINED THAT A HIGHER THAN EXPECTED VITROS TROPI ES RESULT WAS OBTAINED FROM A SINGLE TROPONIN-I FREE SAMPLE ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. ROOT CAUSE FOR THE EVENTS COULD NOT BE DETERMINED; HOWEVER, THE POSSIBILITY THAT A TRANSIENT VITROS 3600 SYSTEM ISSUE OR AN UNEXPECTED REAGENT ISSUE HAD CONTRIBUTED TO THE RESULT COULD NOT BE RULED OUT.

    Description of Event or Problem · 1

    AN ORTHO CLINICAL DIAGNOSTICS SYSTEMS SCIENTIST OBTAINED A HIGHER THAN EXPECTED TEST SIGNAL RESPONSE FROM A SINGLE TROPONIN-I FREE SAMPLE THAT WOULD CORRELATE TO A HIGHER THAN EXPECTED VITROS TROPI ES RESULT ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS TROPI ES RESULT: 0.078 NG/ML VS. EXPECTED <0.012 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO PATIENT SAMPLES WERE AFFECTED IN THIS EVENT AND THERE WAS NO ALLEGATION OF PATIENT HARM MADE; HOWEVER, ORTHO CLINICAL DIAGNOSTICS CANNOT CONFIRM THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WAS TO REOCCUR AT A CUSTOMER FACILITY UNDETECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367964 VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI 1810

    Patients

    Seq Age Sex Outcome Treatment
    1