BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 19493885 · Received June 8, 2024

    Report

    Report Number
    1319681-2024-00034
    Event Type
    Malfunction
    Date Received
    June 8, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 7, 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 HAS DETERMINED THAT A LOWER THAN EXPECTED VITROS CARBAMAZEPINE (CRBM) RESULT WAS OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS CRBM SLIDES LOT 3914-0123-7870 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS IMPROPER PROTOCOL BY THE CUSTOMER RELATED TO HANDLING THE IMMUNOWASH FLUID (IWF) PRIOR TO LOADING ON THE VITROS INSTRUMENT. THE CUSTOMER DID NOT ALLOW THE IWF TO ADEQUATELY WARM UP PRIOR TO LOADING ON THE VITROS XT 7600 SYSTEM. AFTER LOADING A FRESH IWF RESERVOIR USING THE CORRECT PROTOCOL AND PERFORMING THE IWF SYSTEM MAINTENANCE ON THE INSTRUMENT, MAS QC RESULTS RETURNED TO EXPECTATIONS. ADDITIONALLY, VITROS TDM PERFORMANCE VERIFIER RESULTS WERE WITHIN EXPECTATIONS CONFIRMING REAGENT AND INSTRUMENT PERFORMANCE.

    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 CARBAMAZEPINE (CRBM) RESULT WAS OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS CRBM SLIDES LOT 3914-0123-7870 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS OMNICORE LOT OCR2511 LEVEL 3 RESULT OF 9.05 UG/ML VS AN EXPECTED RESULT OF 13.57 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 CRBM RESULTS WERE FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. PATIENT SAMPLES WERE NOT PROCESSED AFTER THE LOWER THAN EXPECTED CONTROL RESULTS WERE OBTAINED. 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 606302.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012850 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown