BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1891290 · Received November 1, 2010

    Report

    Report Number
    2027969-2010-01843
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    September 13, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THIS LAB. ON (B)(6) 2010, PT WENT TO THE HOSPITAL FOR TIA (TRANSIENT ISCHEMIC ATTACK). PT'S TARGET RANGE: 2.5-3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| L