BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIQUICHEK CARDIAC MARKERS PLUS LT

    MDR report key: 2094067 · Received May 6, 2011

    Report

    Report Number
    2016706-2011-00003
    Event Type
    Other
    Date Received
    May 6, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJY
    PMA / PMN Number
    K050537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING AND THE 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). IN ADDITION, THE LABELING INSTRUCTS THE USER TO TREAT ALL HUMAN SOURCE MATERIAL AS POTENTIALLY INFECTIOUS AND SHOULD BE HANDLED WITH THE SAME PRECAUTIONS USED WITH PT SAMPLES. CUSTOMER WAS NOT WEARING SAFETY GLASSES AT THE TIME OF THE EVENT. ROOT CAUSE OF THE EVENT: USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER SPLASHED THE CONTROL IN HER LEFT EYE AND FACE. ON THROWING THE USED SAMPLE CUP WHICH HAD THE CONTROL FROM THE INSTRUMENT TO THE TRASH, IT HIT THE SIDE OF THE GARBAGE CAN AND SPLASHED INTO HER FACE AND LEFT EYE. CUSTOMER IMMEDIATELY WASHED HER EYES FOR ABOUT 1 MINUTE AT AN EYE WASH STATION AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIQUICHEK CARDIAC MARKERS PLUS LT QUALITY CONTROL (ASSAYED AND UNASSAYED) JJY BIO-RAD LABORATORIES NA 23490

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention