BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2111835 · Received June 2, 2011

    Report

    Report Number
    1319681-2011-00125
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 23, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE HIGHER THAN EXPECTED VITROS VANC QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 5600 ANALYZER. AN OCD FIELD ENGINEER PERFORMED 'AS NEEDED' MAINTENANCE AND ADJUSTMENTS TO THE CUVETTE INCUBATOR AND PHOTOMETER SUBSYSTEMS. PERFORMANCE TESTING FOLLOWING MAINTENANCE VERIFIED THAT THE EQUIPMENT WAS RETURNED TO EXPECTED OPERATION. THE ROOT CAUSE OF THE EVENT IS MOST LIKELY DUE TO AN EQUIPMENT RELATED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, HIGHER THAN EXPECTED VITROS VANC QUALITY CONTROL RESULTS (BIORAD LEVEL 3 = 42.29, 40.65, AND 40.76 G/ML VS. EXPECTED RESULT OF 31.2 G/ML) WHILE USING THE VITROS 5600 INTEGRATED 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 OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF HARM TO PATIENTS 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 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1