BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1020252 · Received March 26, 2008

    Report

    Report Number
    1319681-2008-00083
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THE EVENT WAS UNABLE TO DETERMINE THE DEFINITIVE ROOT CAUSE. ANALYSIS OF INSTRUMENT DATALOGGERS WAS UNABLE TO CONFIRM THAT REQUIRED PERIODIC MAINTENANCE BY THE USER HAD BEEN PERFORMED. THIS COULD CONTRIBUTE TO THE GENERATION OF FALSE POSITIVE TROPONIN I RESULTS. THE REPORTING OF THE FALSE POSITIVE TROPONIN I RESULT TO THE PHYSICIAN WAS CAUSED BY A USER ERROR AS THE CUSTOMER WAS NOT FOLLOWING THE ASSAY INSTRUCTIONS FOR USE PROTOCOL RECOMMENDATIONS FOR CONFIRMING POSITIVE RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A FALSE POSITIVE AMI RESULT FOR THE VITROS TROPONIN I ASSAY ON THEIR VITROS ECIQ IMMUNODIAGNOSTIC ANALYZER. THE RESULT WAS REPORTED AND WAS QUESTIONED BY THE PATIENT'S PHYSICIAN. A REPEAT OF THE SAME SAMPLE YIELDED NEGATIVE TROPONIN I RESULTS. FALSELY ELEVATED TROPONIN I RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO ALLEGATIONS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1