BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1657141 · Received April 13, 2010

    Report

    Report Number
    1319681-2010-00071
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    January 26, 2010
    Report Date
    April 13, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS CONCLUDED THAT OPERATOR ERROR IS THE MOST LIKELY CAUSE OF THE LOWER THAN EXPECTED VITROS PHBR RESULT. THERE IS NO EVIDENCE TO SUGGEST THAT THE INSTRUMENT OR THE REAGENT WAS NOT OPERATING AS INTENDED. THE PHBR RESULT OBTAINED BY THE VITROS 5600 ANALYZER WAS ACCURATE, HOWEVER THE VITROS 5600 RESULT CONFIGURATION FOR PHBR WAS SET BY THE OPERATOR TO ALLOW ONLY ONE SIGNIFICANT DIGIT (OTHER THAN ZERO) TO BE PROVIDED. THE PHBR RESULTS CONFIGURATION CAUSED THE LOWER THAN EXPECTED PHBR RESULT TO BE OBTAINED FOR AN OTHERWISE ACCURATELY PRODUCED PHBR RESULT. ONCE THE PHBR RESULTS CONFIGURATION WAS APPROPRIATELY RESET, THE EXPECTED PHBR RESULT WAS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A LOWER THAN EXPECTED VITROS PHBR RESULT FROM A SINGLE AMERICAN ASSOCIATION OF BIOANALYSTS (AAB) PROFICIENCY SAMPLE WHEN TESTED ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT 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 5600 INTEGRATED SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1