BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIROTROL I

    MDR report key: 7246263 · Received February 6, 2018

    Report

    Report Number
    2016706-2018-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 9, 2018
    Report Date
    February 6, 2018
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    KSF
    UDI-DI
    00847661004240
    PMA / PMN Number
    BK930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING FOR VIROTROL INDICATES THIS PRODUCT CONTAINS BIOLOGICAL SOURCE MATERIAL AND SHOULD BE TREATED AS POTENTIALLY INFECTIOUS. EACH HUMAN SERUM OR PLASMA DONOR UNIT USED IN THE PREPARATION OF THIS PRODUCT WAS TESTED FOR THE PRESENCE OF HBSAG, ANTIBODIES TO HIV-1 AND HIV-2 AND ANTIBODIES TO HCV USING LICENSED REAGENTS. 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 (B)(4) AND (B)(4), BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES, OR OTHER EQUIVALENT GUIDELINES.

    Description of Event or Problem · 1

    ON (B)(6) 2018 BIO-RAD QSD TECHNICAL SUPPORT RECEIVED A REPORT FROM (B)(6) REPORTING THAT A LABORATORY INDIVIDUAL HAD SPLASHED VIROTROL I CONTROL INTO HER EYE. THE INDIVIDUAL CLEANED HER EYES BY SPLASHING WATER. SHE ALSO SAW A DOCTOR IN THE HOSPITAL AND WAS TESTED FOR (B)(6) ANTIBODY. THE INCIDENT OCCURRED IN THE HOSPITAL LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89394 VIROTROL I KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS KSF BIO-RAD LABORATORIES, INC. 119100 00847661004240

    Patients

    Seq Age Sex Outcome Treatment
    1 Other