BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 18890650 · Received March 12, 2024

    Report

    Report Number
    1319681-2024-00021
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 14, 2024
    Report Date
    March 12, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KHO
    UDI-DI
    10758750000272
    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 DISCREPANT RESULT WAS OBTAINED BETWEEN VITROS ECI Q SYSTEM AND LABORATORY INFORMATION SYSTEM (LIS). THE DISCREPANT RESULT APPEARS TO BE RELATED TO THE CONFIGURATION OF THE VITROS ECI SYSTEM, THAT WAS REPORTING VITROS TESTO RESULTS IN UNITS OF NMOL/L WHILE THE CUSTOMER'S NON-VITROS LIS WAS REPORTING THE SAME NUMERICAL RESULTS IN UNITS OF NG/ML. PER WKI53815, HEALTH AND SAFETY REPORTABILITY GUIDELINES FOR CLINICAL LABORATORY PRODUCTS: DISCORDANT RESULTS HAVE OCCURRED; HOWEVER, THERE IS NO ALLEGATION OR INDICATION THAT ERRONEOUS RESULTS HAVE OCCURRED ON THE ORTHO SYSTEM. INVESTIGATION HAS DETERMINED THAT THE ORTHO SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCREPANT RESULT WAS OBTAINED BETWEEN VITROS ECI Q SYSTEM AND LABORATORY INFORMATION SYSTEM (LIS). VITROS TESTO RESULT OF 15.3 NG/DL VS THE EXPECTED RESULT OF 441.405 NG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE ERRONEOUS RESULT OF 15.3 NG/DL WAS REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED, OR STOPPED BASED ON THE REPORTED RESULT AND A CORRECTED REPORT OF 441.405 NG/DL WAS LATER ISSUED FOR THE PATIENT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221701 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM CHEMISTRY ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750000272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown