BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 18531456 · Received January 17, 2024

    Report

    Report Number
    0001319681-2024-00005
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 29, 2023
    Report Date
    January 17, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750031610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 A NON-VITROS MAS LEVEL 1 QC FLUID USING VITROS IMMUNODIAGNOSTICS PRODUCTS NT PRO-BNP II REAGENT LOT 0190 IN COMBINATION WITH A VITROS XT 7600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS INSTRUMENT RELATED. IN ADDITION TO THE LOW NT PRO-BNP II LEVEL 1 QC FLUID RESULTS, THE CUSTOMER ALSO OBTAINED LOWER THAN EXPECTED LEVEL 2 QC FLUID RESULTS AT THE SAME TIME. THE VITROS XT 7600 INTEGRATED SYSTEM WAS POSTING FINAL WELL WASH CONDITION CODES WHEN THE LOWER THAN EXPECTED RESULTS WERE OBTAINED. THE ORTHO TSC GUIDED THE CUSTOMER THROUGH TROUBLESHOOTING ACTIONS TO TURN OFF CIRCUIT BOARD 14 AND RESET THE FINAL WELL WASH HEATER CABLE. FOLLOWING THESE ACTIONS BY THE CUSTOMER, THE CUSTOMER SUCCESSFULLY PROCESSED QC FLUIDS WITHOUT ISSUE AND ACCEPTED THE INSTRUMENT BACK INTO USE AS TROUBLESHOOTING ACTIONS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    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 A NON-VITROS MAS LEVEL 1 QC FLUID USING VITROS IMMUNODIAGNOSTICS PRODUCTS NT PRO-BNP II REAGENT LOT 0190 IN COMBINATION WITH A VITROS XT 7600 INTEGRATED SYSTEM. MAS LOT CXL2504 LEVEL 1 QUALITY CONTROL RESULTS OF 197 AND 190 PG/ML VS. EXPECTED RESULT OF 266.4 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 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830395 VITROS XT 7600 INTEGRATED SYSTEM IN-VITRO DIAGNOSTICS JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown