BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1202454 · Received October 8, 2008

    Report

    Report Number
    1319681-2008-00298
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER CALLED OCD IN 2008 AND INDICATED THAT THE LAB DISCOVERED THAT THERE HAD BEEN SAMPLE HANDLING ERROR WHICH CAUSED THE INCORRECT SAMPLE TO BE ASSAYED. REPEAT ANALYSIS OF THE CORRECTLY IDENTIFIED SAMPLE GENERATED APPROPRIATE RESULTS. INVESTIGATION INTO THIS EVENT CONCLUDES THAT THE ROOT CAUSE WAS OPERATOR INDUCED SAMPLE HANDLING ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A REPEATABLE FALSELY ELEVATED RESULT USING VITROS IMMUNODIAGNOSTICS PRODUCT TSH REAGENT. THIS ASSAY WAS RUN ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE FALSELY ELEVATED RESULT WAS REPORTED AND THE PT'S PHYSICIAN QUESTIONED THE RESULT. A REPEAT OF THE SAMPLE ON AN ALTERNATE METHOD YIELDED A LOWER RESULT WHICH WAS THEN REPORTED AND WAS EXPECTED FOR THIS PT. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1