BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 18375955 · Received December 21, 2023

    Report

    Report Number
    0001319681-2023-00065
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 27, 2023
    Report Date
    December 21, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE SAMPLE ID FOR A PATIENT SAMPLE WAS ASSOCIATED WITH THE INCORRECT PATIENT NAME AND TESTS WHEN PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR. THE VITROS 5600 SYSTEM 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. THE CUSTOMER IDENTIFIED THE DISCREPANCY AND NO ERRONEOUS RESULTS WERE REPORTED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A SAMPLE ID FOR A PATIENT SAMPLE WAS ASSOCIATED WITH THE INCORRECT PATIENT NAME AND TESTS WHEN PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035113 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown