BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HIV 1 + 2 CONTROLS

    MDR report key: 1422959 · Received July 24, 2009

    Report

    Report Number
    9680658-2009-00213
    Event Type
    Other
    Date Received
    July 24, 2009
    Date of Event
    June 26, 2009
    Report Date
    June 26, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFO APPEARS IN THE VITROS (B)(6) 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 (B)(6) 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 (B)(6) CONTROL 2 AND 3 ALSO CONTAIN (B)(6) ANTIBODY POSITIVE PLASMA OBTAINED FROM DONORS WHO WHERE TESTED INDIVIDUALLY AND WHO WERE FOUND TO BE NEGATIVE FOR (B)(6)SURFACE ANTIGEN, AND FOR ANTIBODIES TO (B)(6), USING APPROVED METHODS (ENZYME IMMUNOASSAYS). THE (B)(6) 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 OR POTENTIAL INFECTION, HANDLE AS IF CAPABLE TO TRANSMITTING INFECTION." AT THE TIME OF THE EVENT, THE TECHNOLOGIST FLUSHED THE AFFECTED EYE WITH WATER. PROPHYLACTIC TREATMENT WITH COMBIVIR AND KALETRA WAS ADMINISTERED TO THE CUSTOMER. PROPER PERSONAL PROTECTIVE EQUIPMENT WAS NOT BEING WORN AT THE TIME OF THE EVENT. THE CAUSE OF THE EVENT WAS USED ERROR.

    Description of Event or Problem · 1

    A CUSTOMER WAS STRUCK IN THE EYE BY (B)(6) CONTROLS FLUID CONTROL 3 FLUID WHILE LOADING CONTROLS ON THE VITROS ECI. THE CUSTOMER WAS TREATED WITH COMBIVIR AND KALETRA. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HIV 1 + 2 CONTROLS IN VITRO DIAGNOSTIC CONTROL MZF ORTHO-CLINICAL DIAGNOSTICS NA 450

    Patients

    Seq Age Sex Outcome Treatment
    1