BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 18177951 · Received November 20, 2023

    Report

    Report Number
    3007111389-2023-00200
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 27, 2023
    Report Date
    November 20, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750031610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND FROM NON-VITROS MAS OMNI-IMMUNE QUALITY CONTROL FLUID WHEN TESTING WHEN USING VITROS IPTH REAGENT LOT 1741 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS INSTRUMENT RELATED. A WITHIN RUN PRECISION TEST WAS PERFORMED OUTSIDE OF ORTHO ACCEPTABLE GUIDELINES INDICATING THAT THE VITROS XT 7600 INTEGRATED SYSTEM WAS NOT PERFORMING AS EXPECTED AT THE TIME OF THE EVENTS. AN ORTHO FIELD ENGINEER (FE) PERFORMED SERVICE AND MAINTENANCE ACTIONS ON THE VITROS XT 7600 INSTRUMENT, THESE INCLUDED, REPLACING THE SIGNAL REAGENT (SR) PROBES, REPLACEMENT OF SR PUMP B AND REPLACEMENT OF THE WEAR PADS ON THE INCUBATOR. FOLLOWING THESE SERVICE AND MAINTENANCE ACTIONS, A WITHIN RUN PRECISION TEST WAS PERFORMED BY THE BY THE ORTHO FE AND THIS TIME THE RESULTS OBTAINED WERE WITHIN ORTHO ACCEPTABLE GUIDELINES INDICATING THE VITROS XT 7600 INTEGRATED SYSTEM IS NOW PERFORMING AS EXPECTED. ADDITIONALLY, FOLLOWING ORTHO FE ACTIONS, THE CUSTOMER ACCEPTED THE INSTRUMENT BACK INTO ROUTINE USE. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS IPTH REAGENT LOT 1741.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND FROM NON-VITROS MAS OMNI-IMMUNE QUALITY CONTROL FLUID WHEN TESTING WHEN USING VITROS IPTH REAGENT LOT 1741 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT 1, SAMPLE 1 RESULT OF 20.00 PG/ML VS AN EXPECTED RESULT OF 30.00 PG/ML MAS LEVEL 2 RESULTS OF 44.33 PG/ML VS AN EXPECTED RESULT OF 76.30 PG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED PATIENT RESULT WAS OBTAINED WHILE PERFORMING AN IPTH COMPARISON STUDY AND WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 603933.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069642 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown