BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 CONTROLS

    MDR report key: 2120397 · Received June 10, 2011

    Report

    Report Number
    3007111389-2011-00078
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 15, 2011
    Report Date
    September 25, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS AND PRECAUTIONS SECTION OF THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 CONTROLS INSTRUCTIONS FOR USE (IFU) STATE: "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." PERSONAL PROTECTIVE EQUIPMENT (SAFETY GLASSES) WERE NOT BEING WORN AT THE TIME OF THE EVENT. THE OPERATOR WAS SENT TO THE HOSPITAL EMERGENCY ROOM WHERE THE AFFECTED EYE WAS FLUSHED WITH WATER. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN OPERATOR SPLASHED ANTI HIV 1+2 POSITIVE CONTROL INTO HIS FACE, POTENTIALLY COMING INTO CONTACT WITH HIS LEFT EYE. THIS EVENT CONSTITUTES BIOHAZARD EXPOSURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 CONTROLS IN-VITRO DIAGNOSTIC JJX ORTHO-CLINICAL DIAGNOSTICS 131

    Patients

    Seq Age Sex Outcome Treatment
    1