BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 CONTROL

    MDR report key: 2596288 · Received June 1, 2012

    Report

    Report Number
    1319808-2012-00015
    Event Type
    Injury
    Date Received
    June 1, 2012
    Date of Event
    May 3, 2012
    Report Date
    April 19, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS AND PRECAUTIONS SECTION OF THE VITROS ANTI-HIV 1+2 CONTROLS INSTRUCTIONS FOR USE (IFU) STATES: "WARNING: POTENTIALLY INFECTIOUS MATERIAL. HANDLE AS IF CAPABLE OF TRANSMITTING INFECTION. THE VITROS ANTI-HIV 1+2 CONTROLS 2 AND 3 CONTAIN HIV ANTIBODY POSITIVE PLASMA OBTAINED FROM DONORS WHO WERE TESTED INDIVIDUALLY AND WHO WERE FOUND TO BE NEGATIVE FOR HEPATITIS B SURFACE ANTIGEN (HBSAG), AND FOR ANTIBODIES TO HEPATITIS C VIRUS (HCV), USING FDA APPROVED METHODS (ENZYME IMMUNOASSAYS, EIA). THE HIV ANTIBODY POSITIVE PLASMA HAS BEEN HEAT TREATED TO INACTIVATE VIRUSES. HOWEVER, AS NO TESTING METHOD CAN RULE OUT THE RISK OF POTENTIAL INFECTION, HANDLE AS IF CAPABLE OF TRANSMITTING INFECTION." THE CUSTOMER WAS NOT WEARING SAFETY GLASSES OR A FACE SHIELD AT THE TIME OF THE EVENT. IMMEDIATELY AFTER THE INCIDENT, THE OPERATOR FLUSHED THEIR EYES AND MOUTH WITH WATER. THE CUSTOMER WAS SEEN BY A PHYSICIAN WHO PROACTIVELY PUT THE OPERATOR ON A 28-DAY TREATMENT PLAN FOR POTENTIAL (B)(6) EXPOSURE. THE CUSTOMER COULD NOT SPECIFY THE MEDICATION THAT WAS BEING ADMINISTERED. THE CUSTOMER WAS IN APPARENTLY GOOD HEALTH WITH NO IMMEDIATE ISSUES NOTED. AN OCD FIELD ENGINEER EVALUATED THE VITROS 3600 INTEGRATED SYSTEM AND DID NOT IDENTIFY AN INSTRUMENT RELATED EVENT THAT CONTRIBUTED TO THE EVENT. THE ASSIGNABLE CAUSE OF THIS EVENT IS USER ERROR AS THE OPERATOR WAS NOT WEARING SAFETY GLASSES AT THE TIME OF THE EVENT. THE CAUSE OF THE CONTROL MATERIAL SPLASH WAS INVESTIGATED AND IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN OPERATOR WAS SPLASHED WITH QUALITY CONTROL FLUIDS, AND IT COULD NOT BE RULED OUT THAT THE OPERATOR WAS EXPOSED TO THE VITROS IMMUNODIAGNOSTIC PRODUCTS (B)(6) 1+2 CONTROLS, ALTHOUGH THIS COULD NOT BE CONFIRMED. THERE WAS NO IMMEDIATE HARM TO THE SUBJECT AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 CONTROL QUALITY CONTROL FLUID JJX ORTHO-CLINICAL DIAGNOSTICS 0221

    Patients

    Seq Age Sex Outcome Treatment
    1