BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIROTROL I, CLASS F

    MDR report key: 16958732 · Received May 18, 2023

    Report

    Report Number
    2016706-2023-00001
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 18, 2023
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    KSF
    UDI-DI
    00847661005544
    PMA / PMN Number
    BK930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTION FOR USE (IFU) PROVIDED BY BIO-RAD FOR TESTING VIROTROL I, CLASS F INDICATED THE PRODUCT CONTAINS HUMAN SOURCE MATERIALS AND SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS AND HANDLED WITH THE SAME PRECAUTIONS USED WITH PATIENT SPECIMENS IN ACCORDANCE WITH GOOD LABORATORY PRACTICE. EACH HUMAN SERUM OR PLASMA DONOR UNIT USED IN THE PREPARATION OF THIS PRODUCT WAS TESTED AS REQUIRED BY FDA ACCEPTED METHODS. TESTS RESULTS WERE NON-REACTIVE OR NEGATIVE FOR EVIDENCE OF INFECTION DUE TO HUMAN IMMUNODEFICIENCY VIRUS, (HIV), HEPATITIS B VIRUS (HBV) AND HEPATITIS C VIRUS (HCV). HUMAN SOURCE MATERIALS REACTIVE FOR VIRAL HEPATITIS MARKERS AND ANTIBODIES TO RETROVIRUSES USED TO PRODUCE THIS PRODUCT HAVE BEEN TREATED TO INACTIVATE INFECTIOUS AGENTS. HOWEVER, NO KNOWN TEST METHOD CAN ASSURE THAT PRODUCTS DERIVED FROM HUMAN SOURCES WILL NOT TRANSMIT INFECTION. IT IS RECOMMENDED THAT THIS PRODUCT AND ALL HUMAN SPECIMENS BE HANDLED IN ACCORDANCE WITH BIOSAFETY LEVEL 2 PRACTICES AS DESCRIBED IN THE UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) AND NATIONAL INSTITUTES OF HEALTH (NIH), BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES, OR OTHER EQUIVALENT GUIDELINES. THE COMPANY ADDRESS INFORMATION OF THE INITIAL REPORTER WAS NOT PROVIDED TO BIO-RAD.

    Description of Event or Problem · 0

    AT 23:55 ON (B)(6) 2023, A TRAVELING TECHNICIAN SPLASHED VIROTROL I CLASS F, LOT 116820 ON THE RIGHT EYE WHEN THE PRODUCT TUBE WAS OPENED. THE EVENT OCCURRED AT (B)(6) GENERAL HOSPITAL IN (B)(6) VA, USA . THE TECHNICIAN RINSED EYES WITH EYE WASH FOR 15 MINUTES. THE TECHNICIAN HAS THE PRODUCT INSERT ON HAND. BIO-RAD TECHNICAL SERVICE PROVIDED THE PRODUCT SAFETY DATA SHEET AND CERTIFICATE OF ANALYSIS FOR THE VIROTROL I CLASS F, LOT 116820. ON (B)(6) 2023, THE TECHNICIAN NOTIFIED BIO-RAD THAT BASELINE TESTING FOR INFECTIOUS MARKERS WAS PERFORMED AT COMPANY'S OCCUPATIONAL HEALTH DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510478 VIROTROL I, CLASS F KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS KSF BIO-RAD LABORATORIES, INC. 00101F 116820 00847661005544

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other