BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

    MDR report key: 1020248 · Received March 26, 2008

    Report

    Report Number
    9680658-2008-00080
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING STATEMENT APPEARS IN THE INSTRUCTIONS FOR USE FOR VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS: "WARNING: POTENTIALLY INFECTIOUS MATERIAL HUMAN BLOOD PRODUCTS PROVIDED AS COMPONENTS OF THIS PACK HAVE BEEN OBTAINED FROM DONORS WHO WERE TESTED INDIVIDUALLY AND WHO WERE FOUND TO BE NEGATIVE FOR HEPATITIS B SURFACE ANTIGEN AND FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV 1+2) AND HEPATITIS C VIRUS (HCV), USING APPROVED METHODS (ENZYME IMMUNOASSAYS). TREAT AS IF CAPABLE OF TRANSMITTING INFECTION. CARE SHOULD BE TAKE WHEN HANDLING MATERIAL OF HUMAN ORIGIN. ALL SAMPLES SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS. NO TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT HEPATITIS B VIRUS, HCV, HIV 1+2, OR OTHER INFECTIOUS AGENTS ARE ABSENT. HANDLING OF SAMPLES AND ASSAY COMPONENTS, THEIR USE, STORAGE, AND SOLID AND LIQUID WASTE DISPOSAL SHOULD BE IN ACCORDANCE WITH THE PROCEDURES DEFINED BY THE APPROPRIATE NATIONAL BIOHAZARD GUIDELINE OR REGULATION (E.G. NCCLS GUIDELINE M29). NO TREATMENT HAS BEEN INITIATED. PROPER PERSONAL PROTECTIVE EQUIPMENT WAS NOT BEING WORN AT THE TIME OF THE EVENT. THE CAUSE OF THE EVENT WAS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER SPLASHED CONTROL FOR ANTI-HBS INTO THEIR EYES. THE FLUID CONTAINS HUMAN BLOOD PRODUCTS. THERE WAS NO IMMEDIATE HARM TO THE SUBJECT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS IN VITRO DIAGNOSTIC CONTROL LOM ORTHO-CLINICAL DIAGNOSTICS NA 270

    Patients

    Seq Age Sex Outcome Treatment
    1