BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 15924595 · Received December 6, 2022

    Report

    Report Number
    0001319681-2022-00605
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 9, 2022
    Report Date
    December 6, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750031610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE INCORRECT PATIENT NAME AND DATE OF BIRTH WERE ASSOCIATED WITH SIX (6) PATIENT SAMPLES WHEN USING THE VITROS AUTOMATION SOLUTIONS (VAS) INSTRUMENT MANAGER IN COMBINATION WITH THE VITROS XT7600 ANALYZER. THE ASSIGNABLE CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR. A REVIEW OF LOG FILES INDICATES THAT THE CUSTOMER INCORRECTLY PROGRAMMED THE SAMPLES ON THE VITROS AND LIKELY CARRIED THE PATIENT DEMOGRAPHICS FROM ONE SAMPLE TO THE ADDITIONAL FIVE (5) SAMPLES VIA BATCH LOADING. THE VITROS XT7600 INTEGRATED SYSTEM WAS OPERATING AS PROGRAMMED. INITIAL REPORTER EMAIL: (B)(6).

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) BECAUSE THEY IDENTIFIED MULTIPLE PATIENT SAMPLES FOR WHICH THE INCORRECT NAME AND DATE OF BIRTH WERE ASSOCIATED WITH SAMPLE RESULTS OBTAINED WHEN USING THE VITROS XT7600 INTEGRATED SYSTEM IN COMBINATION WITH THE VITROS AUTOMATION SOLUTIONS INSTRUMENT MANAGER. THIS EVENT MEETS POTENTIAL HEALTH AND SAFETY CRITERIA, AS RESULTS COULD HAVE BEEN ASSOCIATED WITH THE WRONG PATIENT AND MIS-REPORTED OUT OF THE LABORATORY LEADING TO INAPPROPRIATE INTERVENTION WITH THE POTENTIAL FOR SERIOUS INJURY TO THE PATIENT. THE MIS-ASSOCIATED RESULTS WERE NOT 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. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240222 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 6844461 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown