BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1577648 · Received January 6, 2010

    Report

    Report Number
    1319681-2010-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2010
    Date of Event
    December 7, 2009
    Report Date
    December 8, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT BIASED QUALITY CONTROL RESULTS WERE OBSERVED FOR MULTIPLE ASSAYS WHILE THE SIGNAL REAGENT ASPIRATION TUBING WAS NOT CORRECTLY PLUGGED INTO THE PURGE STATION. THIS CONDITION CAUSED THE PRESENCE OF SIGNAL REAGENT IN LIQUID AND CRYSTALLIZED FORMS IN THE INSTRUMENT. AFTER CLEANING AND RECONNECTING THE TUBING, ACCEPTABLE QUALITY CONTROL RESULTS WERE OBTAINED. THE ROOT CAUSE OF THE EVENT IS SIGNAL REAGENT (SR) CONTAMINATION IN THE REACTION WELL.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A FALSE REACTIVE (B)(6) AND LOWER THAN EXPECTED TSH RESULTS ON QUALITY CONTROL FLUIDS WHEN USING A VITROS ECI ANALYZER. NO PT RESULTS WERE REPORTED. BIASED RESULTS OF THE MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTIONS. THERE WAS NO REPORT OF PT HARM 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 ECI IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA