BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIQUICHEK UNASSAYED CHEMISTRY CONTROL

    MDR report key: 2431530 · Received June 16, 2011

    Report

    Report Number
    2016706-2011-00004
    Event Type
    Other
    Date Received
    June 16, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BIO-RAD, DIAGNOSTICS GRP.
    Product Code
    JJY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PRODUCT WAS TESTED AND FOUND NON-REACTIVE AT THE DONOR LEVEL PER CURRENT APPLICABLE FDA REQUIREMENTS USING FDA-ACCEPTED METHODS INCLUDING TESTING FOR (B)(6) BY A NUCLEIC ACID TEST (NAT). 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 TECHNICIAN STUCK HER FINGER ON AN INSTRUMENT PROBE THAT CONTAINED LIQUICHEK UNASSAYED CHEMISTRY CONTROL. LEVEL 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIQUICHEK UNASSAYED CHEMISTRY CONTROL LIQUICHEK UNASSAYED CHEMISTRY CONTROL JJY BIO-RAD, DIAGNOSTICS GRP. NA 16452

    Patients

    Seq Age Sex Outcome Treatment
    1