BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 1051535 · Received May 14, 2008

    Report

    Report Number
    9680658-2008-00138
    Event Type
    Malfunction
    Date Received
    May 14, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWED THAT THE ISSUE WAS RELATED TO ONE PATIENT AND ONE SPECIMEN FROM THAT PATIENT. EVALUATION OF THE INSTRUMENT HAS DETERMINED THAT IT WAS OPERATING WITHIN EXPECTED CONDITIONS AFTER THE EVENT. THE SAMPLE GAVE AN ELEVATED TROP I ES RESULT WHICH WAS REPORTED. THE SAME SAMPLE WAS RE-ASSAYED AND RESULTS WITHIN THE NORMAL RANGE FOR TROP I ES WERE OBTAINED. THE INVESTIGATION CONCLUDES THAT A SINGLE NON REPEATABLE FALSELY ELEVATED RESULT WAS OBTAINED. A DEFINITIVE ROOT CAUSE OF THIS EVENT COULD NOT BE IDENTIFIED ALTHOUGH THE INVESTIGATION DETERMINED THAT SAMPLE TUBE PROCESSING WAS TAKING PLACE THAT WAS OUTSIDE OF THE SAMPLE TUBE MANUFACTURES RECOMMENDATIONS, WHICH MAY HAVE CONTRIBUTED TO THE EVENT. A CORRECTED REPORT WAS SENT TO THE PATIENT'S PHYSICIAN PRIOR TO ANY TREATMENT BEING GIVEN. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A NON-REPRODUCIBLE FALSELY ELEVATED VITROS TROP I ES RESULT FOR A PATIENT SAMPLE TESTED ON A VITROS ECI ANALYZER. THE RESULT DID NOT AGREE WITH INDICATIONS FROM OTHER CARDIAC MARKER RESULTS OBTAINED FROM THE SAME SAMPLE. THE LABORATORY DID REPORT THE FALSELY ELEVATED VITROS TROPI ES RESULT BUT THERE WAS NO ALLEGATION OF HARM. A CORRECTED REPORT WAS SENT TO THE PATIENT'S PHYSICIAN.

    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 150

    Patients

    Seq Age Sex Outcome Treatment
    1