BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 21621755 · Received March 17, 2025

    Report

    Report Number
    1319681-2025-00015
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 17, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750031610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 5820 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE NON-REPRODUCIBLE HIGHER THAN EXPECTED PATIENT SAMPLE RESULT WAS LIKELY INSTRUMENT RELATED AS CONTAMINATION WAS FOUND BY THE ORTHO FIELD ENGINEER (FE). ADDITIONALLY, A CONDITION CODE HAD POSTED MULTIPLE TIMES ON THE INSTRUMENT PRIOR TO THE EVENT. FURTHERMORE, IT WAS FOUND THAT THE CUSTOMER WAS NOT CORRECTLY PERFORMING MAINTENANCE AND HAD BEEN IMPROPERLY USING A CLEANING SOLUTION ON THE LUMINOMETER LENS. IT WAS ESTABLISHED THAT THE CUSTOMER WAS NOT PERFORMING ROUTINE CLEANING AND MAINTENANCE ON THE VITROS XT 7600 INTEGRATED SYSTEM IN ACCORDANCE WITH ORTHO GUIDELINES. AN ORTHO FE VISITED THE CUSTOMER SITE AND PERFORMED SERVICE AND MAINTENANCE ACTIONS, INCLUDING CLEANING THE SAMPLE TRAYS, PERFORMING ADJUSTMENTS AND DECONTAMINATING THE MICROWELL SUBSYSTEM. FOLLOWING THESE ACTIONS, THE ORTHO FE CONDUCTED A WITHIN-RUN VITROS TROPI ES PRECISION TEST ON THE INSTRUMENT, WHICH YIELDED ACCEPTABLE RESULTS, INDICATING THAT THE SERVICE ACTIONS RESTORED THE VITROS ANALYZER TO EXPECTED PERFORMANCE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 5820 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT 1 VITROS TROPI ES RESULT OF 4.106 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROPI ES RESULT OF 4.106 NG/ML WAS REPORTED FROM THE LABORATORY. HOWEVER, A CORRECTED REPORT OF <0.012 NG/ML WAS LATER ISSUED FOR THE PATIENT. NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE REPORTED RESULT. THERE WAS NO ALLEGATION OF 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
    1566716 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown