BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, L3

    MDR report key: 1566745 · Received December 16, 2009

    Report

    Report Number
    2016706-2009-00002
    Event Type
    Other
    Date Received
    December 16, 2009
    Date of Event
    November 10, 2009
    Report Date
    November 20, 2009
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJY
    PMA / PMN Number
    K050537
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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) 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 PT SPECIMENS. ROOT CAUSE OF EVENT: USER ERROR.

    Description of Event or Problem · 1

    A LABORATORY EMPLOYEE SPLASHED HIS/HER LEFT EYE WITH LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 3. THE BOTTLE SLIPPED OUT OF HIS/HER HANDS, WHILE CONDUCTING CARDIAC ENZYME TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, L3 REFER TO 510(K) JJY BIO-RAD LABORATORIES NA 23423

    Patients

    Seq Age Sex Outcome Treatment
    1 Other