BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 18268813 · Received December 5, 2023

    Report

    Report Number
    0001319681-2023-00063
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 8, 2023
    Report Date
    December 5, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THE SAMPLE ID FOR A PATIENT SAMPLE WAS ASSOCIATED WITH THE INCORRECT PATIENT NAME AND TEST WHEN PROCESSED ON A VITROS 250 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR. THE VITROS 250 INSTRUMENT WAS OPERATING AS INTENDED. THE CUSTOMER REUSED A SAMPLE ID WITHOUT ENSURING THE PREVIOUSLY PROGRAMMED SAMPLE ID WAS PROCESSED TO COMPLETION OR DELETED PRIOR TO REUSE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THE SAMPLE ID FOR A PATIENT SAMPLE WAS ASSOCIATED WITH THE INCORRECT PATIENT NAME AND TEST WHEN PROCESSED ON A VITROS 250 CHEMISTRY 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 ERRONEOUS 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) AND REPORTABILITY ASSESSMENT 604151.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177862 VITROS 250 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown