BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL

    MDR report key: 823155 · Received February 14, 2007

    Report

    Report Number
    2016706-2007-00001
    Event Type
    Other
    Date Received
    February 14, 2007
    Date of Event
    January 31, 2007
    Report Date
    February 6, 2007
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING AND CERTIFICATE OF ANALYSIS INDICATE THAT EACH HUMAN DONOR UNIT USED TO MANUFACTURE THE PRODUCT WAS TESTED BY FDA ACCEPTED METHODS 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 PROFESSIONAL SPLASHED LEVEL 3 CONTROL MATERIAL IN HER EYE TRYING TO RECAP THE VIAL WHILE HOLDING IT AT CHEST LEVEL. THERE WAS NO IMMEDIATE HARM TO THE LABORATORY PROFESSIONAL AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL * JJY BIO-RAD LABORATORIES NA 75873

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other