BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIQUICHEK IMMUNOASSAY PLUS CONTROL

    MDR report key: 1298368 · Received January 27, 2009

    Report

    Report Number
    2016706-2008-00001
    Event Type
    Other
    Date Received
    January 27, 2009
    Date of Event
    December 29, 2008
    Report Date
    January 14, 2009
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJY
    PMA / PMN Number
    K001373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING AND CERTIFICATE OF ANALYSIS OF THE CONTROL MATERIAL INDICATE THAT EACH HUMAN DONOR UNIT USED TO MANUFACTURE THIS CONTROL WAS TESTED BY FDA ACCEPTED METHODS AND FOUND NON-REACTIVE FOR (B) (6), ANTIBODY TO (B) (6) AND ANTIBODY TO (B) (6). 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. ROOT CAUSE OF EVENT: USER ERROR.

    Description of Event or Problem · 1

    A LABORATORY PROFESSIONAL SPLASHED CONTROL MATERIAL IN HIS LEFT EYE WHILE POURING THE CONTROL MATERIAL INTO A CUP. 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 LIQUICHEK IMMUNOASSAY PLUS CONTROL QUALITY CONTROL MATERIAL JJY BIO-RAD LABORATORIES NA 40702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other