BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 24971021 · Received April 23, 2026

    Report

    Report Number
    1319681-2026-00027
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 22, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE SAMPLE ID (SID) FOR TWO PATIENT SAMPLES WERE MIS-ASSOCIATED WITH THE INCORRECT PATIENT NAMES AND RESULTS WHEN PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR. THE ANALYZER WAS OPERATING AS INTENDED. THE CUSTOMER REUSED AN SID WITHOUT ENSURING THE PREVIOUSLY PROGRAMMED SID WAS PROCESSED TO COMPLETION OR DELETED PRIOR TO REUSE. THE TECHNICAL SOLUTION CENTER REVIEWED INFORMATION CONTAINED IN THE "SAMPLE ID REUSE" SECTION OF THE 5600 INTEGRATED SYSTEM REFERENCE GUIDE. THIS INFORMATION DESCRIBES HOW TO PROPERLY MANAGE SIDS THAT WERE PREVIOUSLY USED AND NOT PROCESSED TO COMPLETION OR DELETED. IF A SAMPLE IS NOT PROCESSED TO COMPLETION, THE SAMPLE PROGRAMMING AND ASSOCIATED DEMOGRAPHICS DATA ARE RETAINED BY THE ANALYZER IN A "PENDING" STATE, AS PER THE DESIGN OF THE SOFTWARE. REUSING A SAMPLE ID ON A DIFFERENT SAMPLE WITHOUT COMPLETION OF THE ORIGINAL REQUEST OR THE DELETION OF THE PENDING TESTING WILL CAUSE THE ORIGINAL INFORMATION TO BE CARRIED FORWARD. NO MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT THE SAMPLE ID (SID) FOR TWO DIFFERENT PATIENT SAMPLES WERE MIS-ASSOCIATED WITH THE INCORRECT PATIENTS NAME AND RESULTS WHEN PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THIS EVENT MEETS THE CRITERIA FOR A REPORTABLE EVENT, AS TEST RESULTS COULD HAVE BEEN MISREPORTED OUT OF THE LABORATORY LEADING TO INAPPROPRIATE INTERVENTION WITH THE POTENTIAL FOR SERIOUS INJURY TO THE PATIENT. 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) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463524 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown