BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 2061093 · Received April 18, 2011

    Report

    Report Number
    3007111389-2011-00039
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROP I ES PATIENT RESULT WAS OBTAINED WHILE USING THE VITROS 5600 SYSTEM. PERFORMANCE TESTING AND REVIEW OF INSTRUMENT DATA DEMONSTRATED THAT THE VITROS 5600 ANALYZER AND TROP I ES REAGENT WERE OPERATING AS EXPECTED AT THE TIME OF THE EVENT. AN OCD FIELD ENGINEER PERFORMED "AS NEEDED" MAINTENANCE TO THE WELL WASH SUBSYSTEM, HOWEVER, THERE WAS NO EVIDENCE THAT SERVICE PERFORMED CORRECTED AN ISSUE RELATED TO THE EVENT. THE INVESTIGATION DID NOT DETERMINE A ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES PATIENT RESULT FOR A SINGLE PATIENT SAMPLE WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULT WAS REPORTED TO THE CLINICIAN, AND A CORRECTED REPORT WAS ISSUED. THERE WAS NO ALLEGATION OF HARM TO THE PATIENT AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 0575

    Patients

    Seq Age Sex Outcome Treatment
    1