BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIQUICHEK IMMUNOASSAY PLUS CONTROL

    MDR report key: 3354924 · Received September 6, 2013

    Report

    Report Number
    2016706-2013-00002
    Event Type
    Other
    Date Received
    September 6, 2013
    Date of Event
    August 23, 2013
    Report Date
    September 6, 2013
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJY
    PMA / PMN Number
    K001373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING AND THE CERTIFICATE OF ANALYSIS INDICATE THAT EACH HUMAN DONOR UNIT USED TO MANUFACTURE THE PRODUCT WAS "TESTED AND FOUND NON-REACTIVE FOR HEPATITIS B SURFACE ANTIGEN (HBSAG), ANTIBODY TO HEPATITIS C (HCV) AND ANTIBODY TO HIV-1/HIV-2." IN ADDITION, THE LABELING INSTRUCTS THE USERS TO TREAT ALL HUMAN SOURCE MATERIAL AS POTENTIALLY INFECTIOUS AND SHOULD BE HANDLED WITH THE SAME PRECAUTIONS USED WITH PATIENT SPECIMENS. THE ROOT CAUSE OF THE EVENT WAS USER ERROR.

    Description of Event or Problem · 1

    A LABORATORY EMPLOYEE SPLASHED LIQUICHEK IMMUNOASSAY PLUS CONTROL INTO HER EYE WHEN THE VIAL FELL FROM HER HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444809 LIQUICHEK IMMUNOASSAY PLUS CONTROL JJY BIO-RAD LABORATORIES 40820

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK