BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 19351852 · Received May 20, 2024

    Report

    Report Number
    1319681-2024-00031
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 21, 2024
    Report Date
    May 10, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750031610
    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 A LOWER-THAN-EXPECTED VITROS NT PRO-BNP II RESULT WAS OBTAINED FROM A NON-VITROS MAS LEVEL 1 QC FLUID USING VITROS IMMUNODIAGNOSTICS PRODUCTS NT PRO-BNP II REAGENT LOT 0280 IN COMBINATION WITH A VITROS XT7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE IS AN INSTRUMENT RELATED ISSUE ASSOCIATED WITH THE FINAL WELL WASH SYSTEM. IN ADDITION TO THE LOW NT PRO-BNP II LEVEL 1 QC FLUID RESULT DETAILED ABOVE, THE CUSTOMER ALSO OBTAINED A LOWER THAN EXPECTED LEVEL 2 QC FLUID RESULT AT THE SAME TIME. THE VITROS XT7600 INTEGRATED SYSTEM WAS POSTING FINAL WELL WASH CONDITION CODES AND RESULT CODES WHEN THE LOWER THAN EXPECTED RESULTS WERE OBTAINED. THE ORTHO TSC HAS REQUESTED A SERVICE GAMEPLAN FOR AN ORTHO FIELD ENGINEER TO ADDRESS THE INSTRUMENT ISSUES, INCLUDING REPLACING THE THERMISTOR MODULE AND ASSOCIATED WIRING. FIELD SERVICE WILL INVESTIGATE AND REPAIR THE INSTRUMENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED VITROS NT PRO-BNP II RESULT WAS OBTAINED FROM A NON-VITROS MAS LEVEL 1 QC FLUID (LOT CXL2602) USING VITROS IMMUNODIAGNOSTICS PRODUCTS NT PRO-BNP II REAGENT LOT 0280 IN COMBINATION WITH A VITROS XT7600 INTEGRATED SYSTEM. MAS LOT CXL2602 LEVEL 1 QUALITY CONTROL RESULTS OF 208.1 PG/ML VS. EXPECTED RESULT OF 300.4 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 RESULT WAS FROM NON-PATIENT FLUID AND WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO 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
    1146592 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown