BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 15330871 · Received August 31, 2022

    Report

    Report Number
    1319681-2022-00037
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 31, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CV
    Reporter Occupation
    OTHER

    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 350 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR. THE VITROS 350 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. EMAIL ADDRESS FOR CONTACT OFFICE IN MFR SITE IS (B)(4).

    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 350 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. 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
    2069725 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown