BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO CONTROLS (HIV P24 ANTIGEN)

    MDR report key: 14702868 · Received June 15, 2022

    Report

    Report Number
    3007111389-2022-00060
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 7, 2022
    Report Date
    June 15, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    OHQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS CONCLUDED THAT AN OPERATOR SPLASHED VITROS HIV COMBO CONTROLS (HIV P24 ANTIGEN) QUALITY CONTROL (QC) FLUID IN THEIR EYE WHILE HANDLING THE PRODUCT. IT WAS ESTABLISHED THAT THE CUSTOMER WAS WEARING EYE PROTECTION WITH SIDE SHIELDS WHEN THE INCIDENT HAPPENED. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT IS USER ERROR. THE INVESTIGATION CONCLUDED THAT SINCE THE PLASMA USED TO MAKE THE CONTROL FLUID HAS BEEN FOUND TO BE NEGATIVE FOR ANTIBODIES TO HIV AND HBV, AND SINCE THE AFFECTED OPERATOR IMMEDIATELY RINSED THE EYE AFTER THE INCIDENT, THE LIKELIHOOD OF THIS OPERATOR TO BE INFECTED WITH HIV OR OTHER PATHOGENS DUE TO THIS INCIDENCE SHOULD BE VERY LOW. HOWEVER, ALL SAMPLES OF HUMAN ORIGIN SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS AND THE POTENTIAL FOR A BLOOD BORNE PATHOGEN INFECTION DUE TO THE EVENT CANNOT BE RULED OUT. THE CUSTOMER REPORTED NO ADVERSE REACTIONS OR SYMPTOMS AS A RESULT OF THIS EVENT AND NO ADDITIONAL MEDICAL TREATMENT WAS SOUGHT. (B)(4).

    Description of Event or Problem · 0

    THE INVESTIGATION HAS CONCLUDED THAT AN OPERATOR SPLASHED VITROS HIV COMBO CONTROLS (HIV P24 ANTIGEN) QUALITY CONTROL (QC) FLUID IN THEIR EYE WHILE HANDLING THE PRODUCT. IT WAS ESTABLISHED THAT THE CUSTOMER WAS WEARING EYE PROTECTION WITH SIDE SHIELDS WHEN THE INCIDENT HAPPENED. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT IS USER ERROR. AS PER A PREVIOUS CONSULT FOR A SIMILAR EVENT ((B)(4)) WITH OCD MEDICAL SAFETY OFFICER DR. (B)(6) ON (B)(6) 2015, THIS EVENT IS CONSIDERED A POTENTIAL SERIOUS INJURY. THE WARNINGS AND PRECAUTIONS SECTION OF THE VITROS HIV COMBO CONTROLS (HIV P24 ANTIGEN) IFU STATE: ¿POTENTIALLY INFECTIOUS MATERIAL 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 APPROPRIATE NATIONAL BIOHAZARD SAFETY GUIDELINE OR REGULATION (E.G. CLSI DOCUMENT M29). HUMAN BLOOD PRODUCTS PROVIDED AS COMPONENTS OF VITROS HIV COMBO CONTROLS 1, 4 AND 5 HAVE BEEN OBTAINED FROM DONORS WHO WERE TESTED INDIVIDUALLY AND FOUND TO BE NEGATIVE FOR HEPATITIS B SURFACE ANTIGEN AND FOR ANTIBODIES TO HIV 1+2 AND HCV, USING APPROVED METHODS (ENZYME IMMUNOASSAYS, EIA). VITROS HIV COMBO CONTROLS 2 AND 3 ALSO CONTAIN HIV POSITIVE PLASMA OBTAINED FROM DONORS WHO WERE TESTED INDIVIDUALLY AND FOUND TO BE NEGATIVE FOR HEPATITIS B SURFACE ANTIGEN AND FOR ANTIBODIES TO HCV, USING APPROVED METHODS (EIA). 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.¿ THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129751 VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO CONTROLS (HIV P24 ANTIGEN) IN-VITRO DIAGNOSTICS OHQ ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown