BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 18721489 · Received February 16, 2024

    Report

    Report Number
    1319681-2024-00011
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 15, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT WHEN THE OPERATOR OPENED THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM'S MICROWELL INCUBATOR THEY WERE SPLASHED IN THEIR EYES WITH FLUID FROM MICROWELLS STUCK TO THE INCUBATOR COVER. THE SPLASH HAPPENED WHEN THE WELLS STUCK TO THE COVER FELL BACK INTO THE INCUBATOR. THE ROOT CAUSE OF THE EXPOSURE IS USER ERROR, AS THE OPERATOR DID NOT USE PROPER PERSONAL PROTECTION EQUIPMENT (SAFETY GLASSES) WHILE OPENING THE MICROWELL INCUBATOR COVER TO ADDRESS A MECHANICAL ISSUE WITH THE MICROWELL INCUBATOR. THE CUSTOMER WAS WEARING THEIR PRESCRIPTION EYEGLASSES BUT NOT SAFETY GLASSES. THE CUSTOMER FLUSHED BOTH EYES IMMEDIATELY AFTER THE EVENT. BLOOD SAMPLES WERE COLLECTED FROM THE OPERATOR FOR INFECTIOUS DISEASE TESTING BUT THE RESULTS OF THE TESTING WERE NOT PROVIDED. THE OPERATOR WILL BE MONITORED FOR ANY HEALTH ISSUES. AS PER MEDICAL CONSULTATION WITH AN ORTHO MEDICAL SAFETY OFFICER RECEIVED ON (B)(6) 2024: EXPOSURE OF THE EYES TO BLOOD-BORNE PATHOGENS SUCH AS HEPATITIS C OR HEPATITIS B CARRIES A RISK OF CONTRACTING AN INFECTION. THERE IS CURRENTLY NO POST-EXPOSURE PROPHYLAXIS FOR HEPATITIS C. HOWEVER, THE RISK OF CONTRACTING HEPATITIS C INFECTION FROM A SPLASH IN THE EYES IS CONSIDERED LOW. HEPATITIS B VIRUS RISK OF INFECTION MAY BE REDUCED IF THE OPERATOR IS IMMUNE TO HEPATITIS B, OR THEY MAY RECEIVE HEPATITIS B VACCINE AND HEPATITIS B BE REDUCED IF THE OPERATOR IS IMMUNE TO HEPATITIS B, OR THEY MAY RECEIVE HEPATITIS B VACCINE AND HEPATITIS B IMMUNOGLOBULIN. DUE TO THE UNCERTAINTY IN THE RISK OF INFECTION, THIS INCIDENCE IS CONSIDERED A SERIOUS INJURY AND IS THEREFORE REPORTABLE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT WHEN THE OPERATOR OPENED THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM'S MICROWELL INCUBATOR THEY WERE SPLASHED IN THEIR EYES WITH FLUID FROM MICROWELLS STUCK TO THE INCUBATOR COVER. THE SPLASH HAPPENED WHEN THE WELLS STUCK TO THE COVER FELL BACK INTO THE INCUBATOR. THIS INCIDENCE IS CONSIDERED AS BLOOD BORNE PATHOGEN EXPOSURE TO THE MUCOSA. THE CUSTOMER WAS PERFORMING PATIENT SAMPLE TESTING USING VITROS MICROWELL ASSAYS INCLUDING THE VITROS ANTI-HCV ASSAY WHEN THE EVENT OCCURRED. DUE TO THE POTENTIAL PATHOGEN CONTENTS AND PATHOGEN CONCENTRATIONS IN THE MICROWELL, A POTENTIAL TRANSMISSION OF BLOOD BORNE PATHOGEN VIA THIS INCIDENT CANNOT BE EXCLUDED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER 32231870 AND REPORTABILITY ASSESSMENT 604909.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432265 VITROS 3600 IMMUNODIAGNOSTIC SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown