BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1298010 · Received December 9, 2008

    Report

    Report Number
    1319681-2008-00362
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 11, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT INCLUDED EVALUATION OF PRE ANALYTICAL SAMPLE HANDLING PROCEDURES AND EVALUATION OF INSTRUMENT DATALOGGER FILES. SAMPLE HANDLING APPEARED APPROPRIATE AND NO ANALYZER ERROR CODES OR FAILURE MODES WERE DETECTED ON THE DATALOGGER FILES DURING THE TIME OF THE EVENT. QUALITY CONTROL SAMPLES WERE WITHIN EXPECTED RANGES AT THE TIME OF THE EVENT. INVESTIGATION INTO THIS EVENT HAS NOT BEEN ABLE TO DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A NON REPEATABLE FALSE POSITIVE RESULT USING VITROS IMMUNODIAGNOSTICS PRODUCT TROPONIN I ES REAGENT. A REPEAT (X2) ANALYSIS OF THE SAMPLE ON THE VITROS ECIQ SYSTEM YIELDED A NEGATIVE RESULT. THE FALSELY ELEVATED RESULT WAS REPORTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC.

    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