BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 10643235 · Received October 7, 2020

    Report

    Report Number
    1319681-2020-00092
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 7, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS DGXN RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QC FLUID, AS WELL AS A VITROS PERFORMANCE VERIFIER FLUID WHEN USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1921-0257-0844 ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS AN ANALYZER RELATED ISSUE. AN ORTHO FIELD ENGINEER (FE) WENT TO THE CUSTOMER SITE TO ADDRESS U90-382 IR WASH ERROR CODES IN ADDITION TO THE VITROS DGXN QC ISSUES. THE FE REPLACED THE IMMUNOWASH FLUID (IWF) PUMP AND VERIFIED ALL IWF ALIGNMENTS. WHILE CHECKING THE ALIGNMENTS, IT WAS DISCOVERED THAT A SPRING WAS MISSING ON THE MICROSLIDE INCUBATOR, WHICH WAS NOT ALLOWING THE MICROSLIDES TO POSITION PROPERLY UNDER THE IWF METERING TIP. THE FE REPLACED THE SPRING ALONG WITH NEW IWF TUBING AND A NEW CM ROTOR BELT. FOLLOWING THE SERVICE ACTIONS AND A CALIBRATION, QC RESULTS AND A WITHIN RUN VITROS DGXN PRECISION WERE WITHIN EXPECTATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT LOWER THAN EXPECTED DIGOXIN (DGXN) RESULTS. THE RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID AND A VITROS PERFORMANCE VERIFIER (PV) FLUID USING VITROS DGXN SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD L3 LOT 85213 RESULT OF 1.98 NG/ML VERSUS THE BASELINE MEAN 3.13 NG/ML. VITROS PVII LOT J6978 RESULTS OF 1.35, 1.35, 1.39, 1.31, 1.07, 1.22, 1,26, 1.26, 1.16, 1.29, 1.41, 1.07, 1.57, 1.37, 1.29, 1.11, AND 1.28 NG/ML VERSUS THE EXPECTED RESULT OF 2.67 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE VITROS DGXN RESULTS WERE OBTAINED WHEN PROCESSING CONTROL FLUIDS. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM 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
    1111190 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1