BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 1052414 · Received May 20, 2008

    Report

    Report Number
    9680658-2008-00143
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 19, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWED THAT THE ISSUE WAS RELATED TO TWO UNIQUE PATIENTS AND ONE SPECIMEN FROM EACH PATIENT. THE SAMPLES THAT GAVE ELEVATED TROP I ES RESULTS WERE REPORTED. PREVIOUS AND SUBSEQUENT SAMPLES HAD NEGATIVE TROPONIN RESULTS. ALL RESULTS WERE REPORTED. THE DEFINITIVE ROOT CAUSE OF THIS EVENT COULD NOT BE IDENTIFIED ALTHOUGH THE INVESTIGATION DETERMINED THAT THE SAMPLE TUBE PROCESSING WAS TAKING PLACE THAT WAS OUTSIDE OF THE SAMPLE TUBE MANUFACTURES RECOMMENDATIONS, WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NON-REPRODUCIBLE FALSELY ELEVATED VITROS TROP I ES RESULTS FOR TWO UNIQUE PATIENT SAMPLES TESTED ON A VITROS ECI ANALYZER. THE RESULTS DID NOT AGREE WITH PREVIOUS AND SUBSEQUENT VITROS TROP I ES RESULTS OBTAINED FROM THE SAME PATIENTS. THE LABORATORY DID REPORT THE FALSELY ELEVATED VITROS TROPI ES RESULT, BUT THERE WAS NO ALLEGATION OF HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCTS TROPONIN I ES REAGENT PACK IN VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS NA 133

    Patients

    Seq Age Sex Outcome Treatment
    1