BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 7474944 · Received May 1, 2018

    Report

    Report Number
    1319681-2018-00035
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    March 3, 2018
    Report Date
    May 1, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS DGXN RESULTS WERE OBTAINED FOR VITROS QUALITY CONTROL FLUIDS USING VITROS DGXN SLIDES LOT 1914-0248-7094, PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM S/N (B)(4). THE MOST LIKELY ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS DGXN QUALITY CONTROL RESULT IS AN INSTRUMENT PERFORMANCE ISSUE, AS A WITHIN-RUN VITROS DGXN PRECISION TEST WAS OUTSIDE PERFORMANCE GUIDELINES, INDICATING THAT THE VITROS 5600 INTEGRATED SYSTEM WAS NOT PERFORMING AS INTENDED. AN ORTHO FIELD ENGINEER IDENTIFIED THAT THE TUBING ON THE IMMUNO WASH FLUID (IWF) METERING ASSEMBLY HAD BEEN INSTALLED INCORRECTLY. AFTER SERVICE WHICH INCLUDED REPLACING THE TUBING AND PERFORMING THE REQUIRED ADJUSTMENTS, ACCEPTABLE PRECISION TEST RESULTS WERE OBTAINED, INDICATING SERVICE ACTIONS HAD RETURNED THE VITROS 5600 SYSTEM TO EXPECTED PERFORMANCE. THERE IS NO EVIDENCE THAT VITROS DGXN SLIDES LOT 1914-0248-7094 WERE NOT PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS DGXN RESULTS FROM VITROS QUALITY CONTROL FLUIDS USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS PV X5905 RESULTS OF: 1.55, 1.75, 1.65, 1.86, 1.50, 1.24, 1.33, 1.85, 1.58, AND 1.28 NG/ML VS. THE BASELINE MEAN VALUE OF 2.44 NG/ML. VITROS TDM PV T5896 RESULTS OF: 1.81 AND 1.71 NG/ML VS. THE RANGE OF MEANS MIDPOINT VALUE OF 2.74 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THE CUSTOMER MADE NO ALLEGATIONS THAT PATIENT SAMPLE RESULTS WERE AFFECTED HOWEVER THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLE RESULTS WERE NOT, OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED.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
    317870 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1