BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 CONTROLS

    MDR report key: 4430316 · Received January 19, 2015

    Report

    Report Number
    3007111389-2015-00018
    Event Type
    Injury
    Date Received
    January 19, 2015
    Date of Event
    January 2, 2015
    Report Date
    January 19, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDES THAT AN OPERATOR SPLASHED (B)(6) CONTROL FLUID IN THEIR EYE WHILE HANDLING THE PRODUCT. THE ROOT CAUSE OF THIS EVENT IS MOST LIKELY USER ERROR. THE WARNINGS AND PRECAUTIONS SECTION OF THE VITROS IMMUNODIAGNOSTIC PRODUCTS (B)(6)CONTROLS INSTRUCTIONS FOR USE (IFU) STATE: "WARNING: POTENTIALLY INFECTIOUS MATERIAL. HANDLE AS IF CAPABLE OF TRANSMITTING INFECTION. THE VITROS (B)(6)1+2 CONTROLS 2 AND 3 CONTAIN (B)(6) PLASMA OBTAINED FROM DONORS WHO WERE TESTED INDIVIDUALLY AND WHO WERE FOUND TO BE NEGATIVE FOR (B)(6) SURFACE ANTIGEN (B)(6), AND FOR ANTIBODIES TO (B)(6), USING FDA APPROVED METHODS (ENZYME IMMUNOASSAYS, EIA). THE (B)(6) PLASMA HAS BEEN HEAT TREATED TO INACTIVATE VIRUSES.¿

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN OPERATOR SPLASHED VITROS IMMUNODIAGNOSTIC PRODUCTS (B)(6) CONTROL INTO HIS EYE WHILE HANDLING THE PRODUCT. THIS EVENT CONSTITUTES BIOHAZARD EXPOSURE. THERE WAS NO ALLEGATION OF OPERATOR HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44383 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 CONTROLS IN-VITRO DIAGNOSTIC JJX ORTHO-CLINICAL DIAGNOSTICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1