BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO CONTROLS (HIV P24 ANTIGEN)

    MDR report key: 14523773 · Received May 27, 2022

    Report

    Report Number
    3007111389-2022-00051
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 2, 2022
    Report Date
    May 27, 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. THE MOST LIKELY ASSIGNABLY CAUSE OF THIS EVENT IS USER ERROR DUE TO IMPROPER HANDLING. IT IS NOTED THE OPERATOR WAS WEARING SAFETY GLASSES. 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. EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS (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. THE MOST LIKELY ASSIGNABLY CAUSE OF THIS EVENT IS USER ERROR DUE TO IMPROPER HANDLING. IT IS NOTED THE OPERATOR WAS WEARING SAFETY GLASSES. AS PER A PREVIOUS CONSULT FOR A SIMILAR EVENT (QERTS IVDRA (B)(6)) WITH OCD MEDICAL SAFETY OFFICER DR. (B)(4) ON (B)(6) 2015, THIS EVENT IS CONSIDERED A POTENTIAL SERIOUS INJURY. THE PLASMA USED TO MAKE THE CONTROL FLUID IS OF HUMAN ORIGIN THAT HAS BEEN FOUND TO BE NEGATIVE FOR ANTIBODIES TO HIV AND HBV USING APPROVED METHODS (ENZYME IMMUNOASSAYS). IN ADDITION, SINCE THE AFFECTED OPERATOR FLUSHED THE EYE WITH SOAP AND WATER IMMEDIATELY AFTER THE INCIDENCE, 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. 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. THIS EVENT IS CONSIDERED A POTENTIAL SERIOUS INJURY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND IVD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704183 VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO CONTROLS (HIV P24 ANTIGEN) IN-VITRO DIAGNOSTICS OHQ ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown