BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 21761927 · Received April 3, 2025

    Report

    Report Number
    1319681-2025-00018
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 9, 2025
    Report Date
    April 1, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE CUSTOMER OBTAINED LOWER THAN EXPECTED CARBAMAZEPINE (CRBM) AND LOWER AND HIGHER PHENYTOIN (PHYT) RESULTS WERE OBTAINED WHILE PROCESSING NON-VITROS THERMOFISHER MAS OMNICORE (OCR) QUALITY CONTROL (QC) FLUIDS USING VITROS CRBM CHEMISTRY PRODUCTS SLIDES AND VITROS PHYT CHEMISTRY PRODUCTS SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS CRBM AND PHYT QC RESULTS IS AN INSTRUMENT RELATED ISSUE. PRIOR TO SERVICE ACTIONS, A VITROS CRBM DIAGNOSTIC WITHIN-RUN PRECISION STUDY FAILED OUTSIDE ORTHO'S GUIDELINES, INDICATING A MECHANICAL ISSUE WITH THE IMMUNOWASH FLUID (IWF) SUBSYSTEM OF THE ANALYZER. THE ORTHO FIELD ENGINEER (FE) WENT ONSITE AND PERFORMED MAINTENANCE ON THE VITROS IWF SUBSYSTEM, INCLUDING CLEANING AND REPLACING THE IWF RESERVOIR WITH A FRESH RESERVOIR AND REPLACING THE IWF TIP. FOLLOWING THESE SERVICE ACTIONS, VITROS CRBM AND VITROS PHYT QUALITY CONTROL RESULTS HAVE RETURNED TO EXPECTATIONS AND NO ADDITIONAL LOWER THAN EXPECTED QUALITY CONTROL RESULTS HAVE BEEN REPORTED. FURTHERMORE, THE LOWER THAN EXPECTED VITROS CRBM AND PHYT RESULTS ALL OCCURRED ON THE SAME DAY AT THE SAME TIME AND DURING THE SAME SAMPLING EVENT. THIS PATTERN WOULD BE OBSERVED IF A MECHANICAL ERROR OR MECHANICAL DISRUPTION WAS THE ATTRIBUTABLE CAUSE OF THE EVENT, AFFECTING MULTIPLE ANALYTES ALL AT ONCE FOR THE IWF SUBSYSTEM. A REVIEW OF THE OTHER ANALYTES PROCESSED DURING THE SAME SAMPLING EVENT ON THE DAY OF THE EVENT REVEALED THAT THE ISSUE WAS ISOLATED TO ONLY THE CHEMISTRIES PROCESSED ON THE IWF SUBSYSTEM (VITROS CRBM AND PHYT), FURTHER SUBSTANTIATING THAT THE ATTRIBUTABLE CAUSE IS A MECHANICAL ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM AND DEMONSTRATING THAT A PREANALYTICAL SAMPLE MIX UP IS NOT A LIKELY CONTRIBUTOR TO THE EVENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED CARBAMAZEPINE (CRBM) AND LOWER AND HIGHER PHENYTOIN (PHYT) RESULTS WERE OBTAINED WHILE PROCESSING NON-VITROS THERMOFISHER MAS OMNICORE (OCR) QUALITY CONTROL (QC) FLUIDS USING VITROS CRBM CHEMISTRY PRODUCTS SLIDES AND VITROS PHYT CHEMISTRY PRODUCTS SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. VITROS CRBM: MAS OCR (LEVEL 2) CRBM RESULT OF <3.0 UG/ML VERSUS THE EXPECTED RESULT OF 10.65 UG/ML VITROS PHYT: MAS OCR (LEVEL 1) PHYT RESULTS OF <3.0 AND <3.0 UG/ML VERSUS THE EXPECTED RESULT OF 5.4 UG/ML MAS OCR (LEVEL 2) PHYT RESULTS OF 6.5 AND 6.1 UG/ML VERSUS THE EXPECTED RESULT OF 14.2 UG/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 VITROS RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND WERE NOT REPORTED FROM THE LABORATORY. IT IS UNKNOWN IF PATIENT SAMPLES HAVE BEEN IMPACTED BY THIS ISSUE. THERE WERE NO REPORTED ALLEGATIONS 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
    731219 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown