BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 4600 CHEMISTRY SYSTEM

    MDR report key: 21929418 · Received April 29, 2025

    Report

    Report Number
    1319681-2025-00022
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 29, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750012343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT DEMOGRAPHICS FOR A PATIENT (B) WERE MIS-ASSOCIATED WITH THE RESULTS OBTAINED FROM A SAMPLE TUBE FROM A DIFFERENT PATIENT (B)(6) WHEN SAMPLES WERE PROCESSED ON A VITROS 4600 CHEMISTRY SYSTEM. THE LIKELY CAUSE OF THE EVENT IS PRE-ANALYTICAL OPERATOR ERROR WHEN LABELING THE PATIENT SAMPLES. THE ORTHO TSC REVIEWED E-CONNECTIVITY DATA AS WELL AS VITROS LABORATORY COMPUTER INTERFACE (LCI) FILES. ACCORDING TO THE DATA REVIEW, THE TRAY MOVEMENTS, POTENTIAL ERROR REACTIONS AND CONDITION CODES DO NOT SHOW ANY INDICATIONS OF ABNORMALITY OR AN ANALYZER ISSUE. THE ANALYZER MOVEMENTS AND METERING EVENT WERE AS EXPECTED. THE SAMPLE PATIENT A RESULTS WERE FROM A SAMPLE IN A TRAY THAT ONLY HAD ONE SAMPLE PLACED IN TRAY 20, CUP 1. THIS MATCHES LCI FILES AND PATIENT REPORT RESULTS. THERE WERE NO INDICATIONS THAT THE VITROS 4600 CHEMISTRY SYSTEM MALFUNCTIONED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT DEMOGRAPHICS FOR A PATIENT (B) WERE MIS-ASSOCIATED WITH THE RESULTS OBTAINED FROM A SAMPLE TUBE FROM A DIFFERENT PATIENT (A) WHEN SAMPLES WERE PROCESSED ON A VITROS 4600 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE CUSTOMER STATED THAT THE DISCREPANT PATIENT SAMPLE RESULTS WERE REPORTED OUT OF THE LABORATORY. HOWEVER, A PHYSICIAN QUESTIONED THE RESULTS AND REPEAT TESTING OCCURRED. NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULTS. THERE WAS NO ALLEGATION OF PATIENT HARM RELATED TO 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
    1581519 VITROS 4600 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750012343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown