BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 18986328 · Received March 27, 2024

    Report

    Report Number
    1319681-2024-00024
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    March 4, 2024
    Report Date
    March 27, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CONCLUDED AN OPERATOR WAS SPLASHED IN THE EYE WHILE CLEANING THE TIP LOCATOR ON THE VITROS 5600 SYSTEM WITH DI WATER AND A COTTON SWAB. IT IS POSSIBLE THAT DRIED SAMPLE COULD HAVE WASHED OFF THE SURFACE OF THE TIP LOCATOR AND INCLUDED IN THE FLUID WHICH SPLASHED INTO THEIR EYE. THE CAUSE OF THIS EVENT IS USER ERROR, AS THE CUSTOMER DID NOT USE PROPER PERSONAL PROTECTION EQUIPMENT (SAFETY GLASSES) WHILE PERFORMING DAILY MAINTENANCE ACTIONS ON THE VITROS 5600 SYSTEM. IT IS POSSIBLE THAT DRIED SAMPLE COULD HAVE WASHED OFF THE SURFACE OF THE TIP LOCATOR AND INCLUDED IN THE FLUID WHICH SPLASHED INTO THEIR EYE. THE POTENTIAL FOR A BLOOD BORNE PATHOGEN INFECTION DUE TO THE EVENT CANNOT BE RULED OUT. THE OPERATOR HAD NO ADVERSE REACTIONS OR SYMPTOMS AS A RESULT OF THIS EVENT, AND NO ADDITIONAL MEDICAL TREATMENT WAS SOUGHT. THE LABORATORY SUPERVISOR WHO REPORTED THE ISSUE AGREED TO CONTACT ORTHO IF FURTHER ASSISTANCE WAS NEEDED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT AN OPERATOR WAS SPLASHED IN THE EYE WHILE CLEANING THE TIP LOCATOR ON THE VITROS 5600 SYSTEM WITH DI WATER AND A COTTON SWAB. IT IS POSSIBLE THAT DRIED SAMPLE COULD HAVE WASHED OFF THE SURFACE OF THE TIP LOCATOR AND INCLUDED IN THE FLUID WHICH SPLASHED INTO THEIR EYE. BASED ON A CONSULTATION WITH THE ORTHO MEDICAL SAFETY OFFICER DR. (B)(6) 2013, THIS EVENT IS CONSIDERED A POTENTIAL SERIOUS INJURY. A SPLASH OF CLINICAL LABORATORY MEDICAL WASTE TO THE FACE OF A HEALTH CARE WORKER IS CONSIDERED AS BLOOD BORNE PATHOGEN EXPOSURE TO SKIN AND MUCOSA. DUE TO THE UNKNOWN PATHOGEN CONTENTS AND PATHOGEN CONCENTRATIONS IN THE WASTE, THE POTENTIAL OF INFECTION DUE TO THE EXPOSURE CANNOT BE RULED OUT; HOWEVER, THE PROBABILITY OF INFECTION SHOULD BE LOW. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER 2601843 AND REPORTABILITY ASSESSMENT 605558.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528190 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown