BEUDAMED
    FDA Adverse Event Other Summary report: N

    LYPHOCHEK UNASSAYED CHEMISTRY CONTROL

    MDR report key: 728260 · Received June 20, 2006

    Report

    Report Number
    2016706-2006-00001
    Event Type
    Other
    Date Received
    June 20, 2006
    Date of Event
    May 31, 2006
    Report Date
    June 6, 2006
    Manufacturer
    BIO-RAD LABS
    Product Code
    JJY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING AND CERTIFICATE OF ANALYSIS INDICATE THAT EACH HUMAN DONOR UNIT USED TO MANFUCTURE 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 PT SPECIMENS. THE ROOT CAUSE OF THE EVENT WAS USER ERROR.

    Description of Event or Problem · 1

    A LAB PROFESSIONAL SPLASHED CONTROL MATERIAL IN HER EYE, AFTER THE CONTROL SLIPPED OUT OF HER HAND AND DROPPED ON THE FLOOR. THERE WAS NO IMMEDIATE HARM TO THE LAB PROFESSIONAL AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYPHOCHEK UNASSAYED CHEMISTRY CONTROL * JJY BIO-RAD LABS NA 15160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other