BEUDAMED
    FDA Adverse Event Other Summary report: N

    METER TRAX CONTROL

    MDR report key: 2011788 · Received February 23, 2011

    Report

    Report Number
    2016706-2011-00001
    Event Type
    Other
    Date Received
    February 23, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING AND CERTIFICATE OF ANALYSIS OF THE CONTROL MATERIAL INDICATE THAT EACH HUMAN WHOLE BLOOD DONOR UNIT USED MANUFACTURE THIS CONTROL WAS TESTED BY FDA- ACCEPTED METHODS AND FOUND (B)(6) 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 PT SPECIMENS. ROOT CAUSE OF EVENT: USER ERROR.

    Description of Event or Problem · 1

    A LAB EMPLOYEE CUT HER FINGER ON A BROKEN HEMATOCRIT THAT CONTAINED METER TRAX CONTROL LEVEL HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METER TRAX CONTROL QUALITY CONTROL MATERIAL JJT BIO-RAD LABORATORIES NA 92373

    Patients

    Seq Age Sex Outcome Treatment
    1