BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2255686 · Received September 20, 2011

    Report

    Report Number
    1319681-2011-00179
    Event Type
    Malfunction
    Date Received
    September 20, 2011
    Date of Event
    August 22, 2011
    Report Date
    September 20, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, IMPRECISE VITROS PSA QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS ECI ANALYZER. AN OCD FIELD ENGINEER PERFORMED "AS NEEDED" MAINTENANCE AND ADJUSTMENTS TO THE REAGENT METERING AND SAMPLE METERING SUBSYSTEMS. PERFORMANCE TESTING FOLLOWING SERVICE VERIFIED THAT THE EQUIPMENT WAS RETURNED TO EXPECTED OPERATION. THE ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, IMPRECISE VITROS PSA QUALITY CONTROL RESULTS (ONCOLOGY CONTROL LEVEL 2 = 9.16 NG/ML VS. EXPECTED RESULT OF 12.80 NG/ML; ONCOLOGY CONTROL LEVEL 3 = 25.8, 26.5, 27.1, 25.0, 25.6, 25.9, 25.1, 25.2, 25.5, 25.5, 25.5, 25.3 NG/ML VS. EXPECTED RESULT OF 37.0 NG/ML) WHILE USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENTS WERE TO RECUR WITH PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC. COMPLAINT NUMBER (B)(4).

    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