BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 16822744 · Received April 27, 2023

    Report

    Report Number
    0001319681-2023-00027
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    March 20, 2023
    Report Date
    April 26, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT FALSE NON-REACTIVE PATIENT SAMPLE RESULTS WERE OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS ANTI-HCV (AHCV) LOT 5320 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE PATIENT WAS KNOWN TO BE INFECTED WITH HEPATITIS C, THEREFORE THE VITROS AHCV RESULTS ARE FALSE NON-REACTIVE RESULTS. THE MOST LIKELY CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE. HIGH SD VALUES WERE OBSERVED FOR THE FINAL WELL WASH SUBSYSTEM OF THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM PRIOR TO SERVICE ACTIONS AND AN ORTHO FIELD ENGINEER (FE) REPLACED THE FINAL WELL WASH MOTOR, TWO FILTERS AND SR PROBES. FOLLOWING ORTHO FE ACTIONS, A WITHIN-RUN DIAGNOSTIC PRECISION TESTING INDICATED ACCEPTABLE INSTRUMENT PERFORMANCE AND AN ACCEPTABLE VITROS AHCV RESULT OF 2.15 S/C (REACTIVE) WAS OBTAINED FROM THE SAME SAMPLE FOR THE PATIENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT FALSE NON-REACTIVE PATIENT SAMPLE RESULTS WERE OBTAINED WHEN A SINGLE PATIENT SAMPLE THAT WAS TESTED USING VITROS ANTI-HCV (AHCV) LOT 5320 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE PATIENT WAS KNOWN TO BE INFECTED WITH HEPATITIS C, THEREFORE THE VITROS AHCV RESULTS ARE FALSE NON-REACTIVE RESULTS. PATIENT 1, VITROS AHCV RESULTS OF 0.74 AND 0.65 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REACTIVE VITROS AHCV RESULTS FOR PATIENT 1 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 601630.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613038 VITROS 3600 IMMUNODIAGNOSTIC SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 6802783 10758750002979

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown