BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYPHOCHEK IMMUNOASSAY PLUS CONTROL

    MDR report key: 5417986 · Received February 8, 2016

    Report

    Report Number
    2016706-2016-00001
    Event Type
    Injury
    Date Received
    February 8, 2016
    Date of Event
    January 7, 2016
    Report Date
    February 7, 2016
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJY
    PMA / PMN Number
    K981532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING FOR LYPHOCHEK IMMUNOASSAY PLUS CONTROL INDICATES THAT EACH HUMAN DONOR UNIT USED TO MANUFACTURE THIS CONTROL WAS "TESTED BY FDA ACCEPTED METHODS AND FOUND (B)(6). IN ADDITION, THE LABELING FOR LYPHOCHEK IMMUNOASSAY PLUS CONTROL INSTRUCTS THE USERS TO TREAT ALL HUMAN SOURCE MATERIAL AS POTENTIALLY INFECTIOUS AND SHOULD BE HANDLED WITH THE SAME PRECAUTIONS USED WITH PATIENT SPECIMENS.

    Description of Event or Problem · 1

    CUSTOMER WAS OPENING A GLASS VIAL OF THE QUALITY CONTROL WHEN A PIECE OF BROKEN GLASS CUTTING HER RIGHT THUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74377 LYPHOCHEK IMMUNOASSAY PLUS CONTROL QUALITY CONTROL MATERIAL JJY BIO-RAD LABORATORIES 40311

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other