BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1959728 · Received January 13, 2011

    Report

    Report Number
    1319681-2011-00014
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 3, 2010
    Report Date
    January 13, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A FALSE POSITIVE (B)(6) IGM RESULT OCCURRED WHILE USING THE VITROS 3600 ANALYZER. THE INVESTIGATION CONFIRMED THAT THE SAMPLE INVOLVED WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE ROOT CAUSE FOR THE EVENT IS UNKNOWN. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE ISSUE WAS ISOLATED TO ONE PATIENT, AND NO OTHER VITROS (B)(6) IGM PATIENT RESULTS WERE QUESTIONED. PERFORMANCE TESTING DEMONSTRATED THAT THE VITROS 3600 ANALYZER AND VITROS (B)(6) IGM REAGENT WERE OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A NON-REPRODUCIBLE FALSE POSITIVE VITROS (B)(6) IGM RESULT FOR A SINGLE PATIENT SAMPLE WHILE USING THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE INITIAL RESULT WAS NOT REPORTED TO THE CLINICIAN. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 3600 IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER LOL ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1