BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 4180629 · Received October 17, 2014

    Report

    Report Number
    1319681-2014-00161
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 17, 2014
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER AND LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS WERE OBTAINED FROM TWO DIFFERENT VITROS PHYT SLIDE LOTS ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS ANALYZER RELATED. PHYT PRECISION TESTS, USING TWO DIFFERENT SLIDE LOTS, WERE OUTSIDE OF OCD GUIDELINES. OCD FIELD SERVICE PERFORMED SERVICE ACTIONS TO MULTIPLE SUBSYSTEMS OF THE 5600 ANALYZER. FOLLOWING THESE SERVICE ACTIONS, ACCEPTABLE WITHIN-RUN PRECISION TEST RESULTS WERE OBTAINED INDICATING THAT SERVICE ACTIONS HAVE RESOLVED THIS ISSUE. THE INVESTIGATION FOUND NO EVIDENCE THE VITROS PHYT REAGENT MALFUNCTIONED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER AND LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS OBTAINED FROM TWO DIFFERENT VITROS PHYT SLIDE LOTS ON A VITROS 5600 INTEGRATED SYSTEM. VITROS PHYT LOT 2613-0150-6311 AND VITROS TDM III B2957: 19.54, 21.12, 32.83, 30.46 VERSUS EXPECTED 25.4 UG/ML. VITROS PHYT LOT 2613-0150-6311 AND VITROS TDM III H3424: 35.6274, 36.352, 35.2643, 36.4359, 34.7258, 32.7684, 31.8111, 35.2806, 35.112 VERSUS EXPECTED 25.8 UG/ML. VITROS PHYT LOT 2614-0151-6737 AND VITROS TDM III H3424: 34.92, 31.332, 31.1233, 32.3057, 30.7806, 34.6505, 35.3886 VERSUS EXPECTED 25.2 UG/ML. VITROS PHYT LOT 2614-0151-6737 AND BIORAD 40833: 30.91, 32.75, 33.14, 30.85 VERSUS EXPECTED 25.3 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT SAMPLES WERE RUN FOR VITROS PHYT WHILE QUALITY CONTROL RESULTS WERE OUTSIDE OF EXPECTED RANGES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663086 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE

    Patients

    Seq Age Sex Outcome Treatment
    1