BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 21209587 · Received January 22, 2025

    Report

    Report Number
    1319681-2025-00003
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 20, 2024
    Report Date
    January 21, 2025
    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 HIGHER AND LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) QUALITY CONTROL RESULTS WERE OBTAINED FROM NON-VITROS MAS CONTROL FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-55-2478 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE. UNACCEPTABLE RESULTS WERE OBTAINED FROM TWO DIFFERENT LOTS OF VITROS VANC REAGENT AND FROM MULTIPLE PACKS OF EACH LOT. AN ORTHO FIELD ENGINEER COMPLETED SERVICE ACTIONS ON THE VITROS XT 7600 SYSTEM WHICH INCLUDED CLEANING THE CUVETTE INCUBATOR AND SENSORS, REPLACING THE UIA METERING PUMP, METERING DSP BOARD, Z GUIDE, AND PERFORMING ALL NECESSARY ADJUSTMENTS. POST SERVICE QUALITY CONTROL RESULTS WERE WITHIN EXPECTATIONS. ADDITIONALLY, A POST SERVICE VITROS VANC PRECISION TEST YIELDED RESULTS THAT WERE WITHIN ORTHO ACCEPTABLE GUIDELINES. THERE HAS BEEN NO REPORTED RECURRENCE FROM THE CUSTOMER OF HIGHER OR LOWER THAN EXPECTED VITROS VANC RESULTS SINCE SERVICE ACTIONS WERE PERFORMED BY THE ORTHO FIELD ENGINEER.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER AND LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) QUALITY CONTROL RESULTS WERE OBTAINED FROM NON-VITROS MAS CONTROL FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-55-2478 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS LOT LIA2802 LEVEL 1 RESULTS OF 20.39, 26.35 AND >50.0 UG/ML VS AN EXPECTED RESULT OF 6.88 UG/ML MAS LOT LIA2802 LEVEL 3 RESULTS OF <5, <5, <5, <5, <5, <5 AND <5 UG/ML VS AN EXPECTED RESULT OF 28.5 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 HIGHER AND LOWER THAN EXPECTED RESULTS WERE FROM QC FLUIDS AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN 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
    681602 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown