BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 21529368 · Received March 5, 2025

    Report

    Report Number
    1319681-2025-00013
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    January 31, 2025
    Report Date
    March 5, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) WAS NOTIFIED BY AN ORTHO FIELD APPLICATION SPECIALIST TO REPORT THAT THE INCORRECT PATIENT NAME AND DATE OF BIRTH WERE ASSOCIATED WITH A PATIENT SAMPLE WHEN USING THE VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT WAS NOT DETERMINED; HOWEVER IT WAS CONCLUDED TO MOST LIKELY BE USER ERROR. A REVIEW OF VITROS 5600 ANALYZER LOG FILES INDICATES THAT THE CUSTOMER INCORRECTLY PROGRAMMED THE SAMPLE ON THE VITROS AND LIKELY CARRIED THE PATIENT DEMOGRAPHICS FROM ONE SAMPLE TO ANOTHER SAMPLE VIA MANUALLY PROGRAMMING. THE VITROS ANALYZER LCI FILES AND DEBUG FILES WERE OVERWRITTEN AND THEREFORE NO FURTHER INVESTIGATION COULD OCCUR. THE VITROS 5600 INTEGRATED SYSTEM WAS OPERATING AS PROGRAMMED.

    Description of Event or Problem · 0

    THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) WAS NOTIFIED BY AN ORTHO FIELD APPLICATION SPECIALIST TO REPORT THAT THE INCORRECT PATIENT'S NAME AND DATE OF BIRTH WERE ASSOCIATED WITH A PATIENT SAMPLE WHEN USING THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE CUSTOMER IDENTIFIED THE DISCREPANCY, AND NO MIS-ASSOCIATED PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374062 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown