BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCT ANTI-HIV 1 +2 CONTROLS

    MDR report key: 1440695 · Received August 5, 2009

    Report

    Report Number
    9680658-2009-00223
    Event Type
    Other
    Date Received
    August 5, 2009
    Date of Event
    July 7, 2009
    Report Date
    July 7, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION APPEARS IN THE VITROS ANTI- HIV 1 + 2 CONTROL INSTRUCTIONS FOR USE: "TREAT AS IF CAPABLE OF TRANSMITTING INFECTION. USE CAUTION WHEN HANDLING MATERIAL OF HUMAN ORIGIN. CONSIDER ALL SAMPLES POTENTIALLY INFECTIOUS. NO TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT HEPATITIS B VIRUS, HEPATITIS C VIRUS (HCV), HUMAN IMMUNODEFICIENCY VIRUS (HIV 1+2) OR OTHER INFECTIOUS AGENTS ARE ABSENT. HANDLE, USE, STORE AND DISPOSE OF SOLID AND LIQUID WASTE FROM SAMPLES AND TEST COMPONENTS, IN ACCORDANCE WITH THE PROCEDURES DEFINED BY THE APPROPRIATE NATIONAL BIOHAZARD SAFETY GUIDELINE OR REGULATION (E.G. NCCLS GUIDELINE M29)." IN ADDITION, THE IFU STATES: "THE VITROS ANTI-HIV 1+2 CONTROLS 2 AND 3 ALSO CONTAIN HIV ANTIBODY POSITIVE PLASMA OBTAINED FROM DONORS WHO WERE TESTED INDIVIDUALLY AND WHO WERE FOUND TO BE NEGATIVE FOR HEPATITIS B SURFACE ANTIGEN, AND FOR ANTIBODIES TO HEPATITIS C VIRUS (HCV), USING APPROVED METHODS (ENZYME IMMUNOASSAYS). THE HIV ANTIBODY POSITIVE PLASMA HAS BEEN TREATED IN ORDER TO REDUCE THE TITER OF POTENTIALLY INFECTIOUS VIRUS. 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 CUSTOMER FLUSHED THE AFFECTED EYE WITH WATER. PROPHYLACTIC ANTI-VIRAL TREATMENT WAS ADMINISTERED TO THE CUSTOMER. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER SPLASHED VITROS ANTI-HIV 1 + 2 AND VITROS ANTI-HCV CONTROLS FLUIDS IN THEIR EYE WHILE DISPOSING OF THE QUALITY CONTROL FLUID VIALS. THE CUSTOMER WAS GIVEN ANTI-VIRAL THERAPY. NOTE: THIS FORM 3500A IS ONE OF TWO MDRS FOR THIS EVENT. TWO DEVICES WERE INVOLVED. VITROS ANTI-HIV 1+2 CONTROLS AND VITROS ANTI-HCV CONTROLS. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCT ANTI-HIV 1 +2 CONTROLS IN VITRO DIAGNOSTIC CONTROL MZO ORTHO-CLINICAL DIAGNOSTICS NA 430

    Patients

    Seq Age Sex Outcome Treatment
    1