BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 19973457 · Received August 13, 2024

    Report

    Report Number
    1319681-2024-00046
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 13, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS NT PRO-BNP II RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS CLINIQA CARDIAC MARKER QUALITY CONTROL (QC) FLUIDS LOT 231011 VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP II REAGENT LOT 0910 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE IS AN INSTRUMENT RELATED ISSUE. AN ORTHO FIELD ENGINEER (FE) PERFORMED SERVICE AND MAINTENANCE ACTIONS ON NUMEROUS SUBSYSTEMS OF THE VITROS 5600 INTEGRATED SYSTEM. THESE INCLUDED CLEANING THE INCUBATOR RINGS, BASEPLATE AND INCUBATOR WELL SHUTTLE. ADJUSTED THE WELL WASH AND SIGNAL REAGENT SYSTEMS AND REPLACED THE PROBOSCIS. FOLLOWING THESE ORTHO FE ACTIONS, THE CUSTOMER SUCCESSFULLY PROCESSED QUALITY CONTROL FLUIDS AND ACCEPTED THE INSTRUMENT BACK INTO ROUTINE USE. ORTHO FE ACTIONS PERFORMED HAVE RETURNED THE INSTRUMENT TO EXPECTED OPERATION AND ALL REQUIRED DOCUMENTATION WAS GIVEN TO THE CUSTOMER. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS NT PRO-BNP II REAGENT LOT 0910.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS NT PRO-BNP II RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS CLINIQA CARDIAC MARKER QUALITY CONTROL (QC) FLUIDS LOT 231011 USING VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP II REAGENT LOT 0910 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. CLINIQA LOT 231011 LEVEL 2 QUALITY CONTROL RESULTS OF 80.79, 20.00, 20.00, 92.61 AND 92.69 PG/ML VS. EXPECTED RESULT OF 137.7 PG/ML. CLINIQA LOT 231011 LEVEL 3 QUALITY CONTROL RESULTS OF 1659, 1883, 1742 AND 1760 PG/ML VS. EXPECTED RESULT OF 2348.5 PG/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 LOWER THAN EXPECTED NT PRO-BNP II QUALITY CONTROL RESULTS WERE FROM NON-PATIENT FLUIDS AND WERE NOT REPORTED FROM 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 (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 606987.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895626 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown