BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 18371560 · Received December 21, 2023

    Report

    Report Number
    0001319681-2023-00064
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 26, 2023
    Report Date
    December 21, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KHO
    UDI-DI
    10758750000272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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, VITROS TROPI ES RESULT WAS OBTAINED FROM A VITROS BUFFER SOLUTION (SPECIALTY DILUENT 3) KNOWN TO BE TROPONIN FREE WHEN TESTED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE MOST LIKELY CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR DUE TO CLEANING MAINTENANCE OF A NON-VITROS ABBOTT ID NOW SYSTEM WITH CHLORINE BASED CLEANING SOLUTION IN THE VICINITY OF THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM, LEADING TO VAPOR CONTAMINATION OF THE MICROWELL INCUBATOR. THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IN USE DURING THE EVENT WAS OPERATING AS INTENDED. THE VITROS USER GUIDE INSTRUCTS CUSTOMERS NOT TO USE CHLORINE-BASED CLEANING SOLUTIONS AS THEY HAVE THE POTENTIAL TO CAUSE ERRONEOUS RESULTS ON THE VITROS SYSTEM.

    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 VITROS TROPI ES RESULT WAS OBTAINED FROM A VITROS BUFFER SOLUTION (SPECIALTY DILUENT 3) KNOWN TO BE TROPONIN FREE WHEN TESTED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. SPECIALTY DILUENT 3 RESULT OF 0.059 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 WAS FROM NON-PATIENT FLUID AND WAS 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 604354.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152046 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM CHEMISTRY ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750000272

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown