BEUDAMED
    FDA Adverse Event Other Summary report: N

    LYPHOCHEK IMMUNOASSAY PLUS CONTROL

    MDR report key: 2845084 · Received November 9, 2012

    Report

    Report Number
    2016706-2012-00002
    Event Type
    Other
    Date Received
    November 9, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJY
    PMA / PMN Number
    K981532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT LABELING AND CERTIFICATE OF ANALYSIS CLEARLY STATE THAT EACH HUMAN DONOR UNIT USED TO MANUFACTURE THIS CONTROL WAS "TESTED BY FDA ACCEPTED METHODS AND WAS 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.

    Description of Event or Problem · 1

    LABORATORY TECHNICIAN CUT HER FINGER WHILE OPENING A VIAL CONTAINING LYPHOCHEK IMMUNOASSAY PLUS CONTROL, LEVEL 1. THE BOTTLE WAS NOT BROKEN, AND THERE WERE NO CHIPS ON THE BOTTLE. THE LABORATORY TECHNICIAN WAS WEARING GOVES AT THE TIME OF THE EVENT. THE LABORATORY SUPERVISOR AND LABORATORY EMPLOYEE ARE UNAWARE OF WHAT MATERIAL CUT HER FINGER, BUT WAS TAKEN TO THE EMERGENCY ROOM (ER) FOR TREATMENT. IN THE ER, THE LABORATORY EMPLOYEE WAS TESTED FOR VIRALS, GIVEN A TETANUS SHOT, AND GIVEN A BANDAGE FOR THE FINGER CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYPHOCHEK IMMUNOASSAY PLUS CONTROL NONE JJY BIO-RAD LABORATORIES NA 40251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN