BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1695525 · Received May 21, 2010

    Report

    Report Number
    1319681-2010-00101
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 21, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT BIASED VITROS PSA QUALITY CONTROL RESULTS OCCURRED ON A VITROS ECIQ AND ECI IMMUNODIAGNOSTIC SYSTEM FOLLOWING A CALIBRATION EVENT. NO ANALYZER MALFUNCTION WAS IDENTIFIED. THE OPEN VIAL AGE AND PROPER HANDLING OF THE PSA CALIBRATORS USED COULD NOT BE CONFIRMED. THERE WAS INSUFFICIENT INVENTORY OF THE PRODUCT TO CONTINUE THE INVESTIGATION. ACCEPTABLE PERFORMANCE WAS OBSERVED ON BOTH ANALYZERS WHEN A DIFFERENT LOT OF CALIBRATOR FLUIDS AND PSA REAGENT WERE USED. THE INVESTIGATION INTO THIS EVENT CONCLUDES THAT THE ROOT CAUSE OF THE EVENT IS UNKNOWN AND THE POSSIBILITY OF IMPROPER PRE-ANALYTICAL HANDLING OF THE PSA CALIBRATOR FLUIDS USED TO CALIBRATE BOTH ANALYZERS COULD NOT BE RULED OUT AS POTENTIAL ROOT CAUSE.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS PSA QUALITY CONTROL RESULTS ON A VITROS ECIQ AND ECI IMMUNODIAGNOSTIC SYSTEM. NO BIASED PATIENT RESULTS WERE REPORTED. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION SHOULD THEY OCCUR ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.THIS REPORT IS ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED.THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT # 1120707 & 1121394/ IVD 170602.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1