BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 23977801 · Received January 6, 2026

    Report

    Report Number
    1319681-2026-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 9, 2025
    Report Date
    January 6, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION HAS DETERMINED THAT RESULTS FROM SIX DIFFERENT PATIENT SAMPLES WERE ASSOCIATED WITH THE WRONG PATIENT SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THE ATTRIBUTABLE CAUSE OF THIS EVENT IS USER ERROR, AS IT WAS CONFIRMED THAT AN UNTRAINED LABORATORY STAFF MEMBER MANUALLY ROTATED THE AFFECTED SAMPLE TRAY AFTER THE TRAY HAD BEEN SCANNED BY THE VITROS 5600 INTEGRATED SYSTEM.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT RESULTS FROM SIX DIFFERENT PATIENT SAMPLES WERE ASSOCIATED WITH THE WRONG PATIENT SAMPLES 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. THE INITIAL RESULTS FROM THE AFFECTED SAMPLE TRAY WERE RELEASED FROM THE LABORATORY AND QUESTIONED BY PHYSICIANS AS THE RESULTS DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENTS. THE REPEAT RESULTS OF EACH PATIENT SAMPLE WERE BELIEVED TO BE THE TRUE RESULTS FOR EACH PATIENT. CORRECTED REPORTS WERE ISSUED FOR EACH PATIENT. NO TREATMENT WAS STARTED, STOPPED, OR ALTERED IN ANY WAY DUE TO THIS EVENT. THERE HAS BEEN 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
    37955 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown