BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 16658717 · Received March 31, 2023

    Report

    Report Number
    0001319681-2023-00018
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 7, 2023
    Report Date
    March 31, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT HIGHER THAN EXPECTED VITROS IGA RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES AND A VITROS PROTEIN PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS IGA REAGENT LOT 1503-12-9804 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS IGA RESULTS IS A SUBOPTIMAL CALIBRATION DUE TO AN INSTRUMENT RELATED ISSUE. THE PARAMETERS OF THE INITIAL CALIBRATION EVENT WERE ATYPICAL WHEN COMPARED TO THE DATABASE VALUES. AN ORTHO FIELD ENGINEER (FE) PERFORMED SERVICE ACTIONS ON THE VITROS 5600 SYSTEM THAT INCLUDED ADJUSTMENTS TO THE SUPPLY 3, THE CUVETTE INCUBATOR, THE SAMPLE CENTER VERSATIP RING AND MULTIPLE METERING SYSTEMS. ADDITIONALLY, THE FE HAD FOUND A BUILD-UP OF GLUE IN THE CUVETTE INCUBATOR LIKELY FROM THE STICKER PEELS FROM THE CUVETTES. THE FE CLEANED THE CUVETTE INCUBATOR AND THEN PERFORMED A WATER BLANK TEST FOR THE CUVETTE INCUBATOR. FOLLOWING THE SERVICE ACTIONS ON THE VITROS 5600 SYSTEM, THE CUSTOMER RECALIBRATED VITROS IGA LOT 1503-12-9804. SINCE SERVICE ACTIONS AND THE RECALIBRATION WERE PERFORMED, VITROS IGA RESULTS HAVE RETURNED TO EXPECTATIONS.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS IGA RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES AND A VITROS PROTEIN PERFORMANCE VERIFIER (PPV) PROCESSED USING VITROS CHEMISTRY PRODUCTS IGA REAGENT LOT 1503-12-9804 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 SAMPLE RESULT OF 46 MG/DL VS AN EXPECTED RESULTS OF 39 MG/DL. PATIENT 4 SAMPLE RESULT OF 128 MG/DL VS AN EXPECTED RESULT OF 85 MG/DL. PATIENT 5 SAMPLE RESULT OF 105 MG/DL VS AN EXPECTED RESULT OF 72 MG/DL. VITROS PPV I LOT L9246 RESULTS OF 104.9, 104.2 AND 104.2 MG/DL VS AN EXPECTED RESULT OF 76.0 MG/DL. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS IGA RESULTS WERE OBTAINED FROM A CONTROL FLUID AND FROM PATIENT SAMPLES DURING A LOT TO LOT CORRELATION AND WERE NOT REPORTED OUT OF THE LABORATORY. HOWEVER, THE CUSTOMER STATED THAT OTHER PATIENT SAMPLE RESULTS HAD BEEN RELEASED FROM THE LABORATORY. THE CUSTOMER WAS UNABLE TO CONFIRM IF ANY TREATMENT HAD BEEN INITIATED, ALTERED OR STOPPED BASED ON ANY OF THE RESULTS. 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 (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720408 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 6802413 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown