BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIQUICHEK UNASSAYED CHEMISTRY CONTROL

    MDR report key: 1736336 · Received June 23, 2010

    Report

    Report Number
    2016706-2010-00002
    Event Type
    Other
    Date Received
    June 23, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 23, 2010
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJY
    PMA / PMN Number
    K914255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING AND THE CERTIFICATES 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 (B)(6), 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.

    Description of Event or Problem · 1

    A MEDICAL TECHNOLOGIST IN A LABORATORY SPLASHED LIQUICHEK UNASSAYED CHEMISTRY CONTROL INTO HER LEFT EYE. THE CONTROL MATERIAL SPLASHED BACK INTO HER EYE WHEN SHE DUMPED OPEN MICRO SAMPLE CUPS INTO THE HAZARDOUS WASTE TRASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIQUICHEK UNASSAYED CHEMISTRY CONTROL LIQUICHEK UNASSAYED CHEMISTRY CONTROL JJY BIO-RAD LABORATORIES NA 16470

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other