BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 3093764 · Received April 30, 2013

    Report

    Report Number
    2027969-2013-00355
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 3.1, LAB: 5.0. TIME BETWEEN TESTING WAS REPORTED AS ONE HOUR. THERAPEUTIC RANGE IS 2.0 - 3.0. IT WAS REPORTED THE PATIENT WAS TAKEN TO THE HOSPITAL FOR DIZZINESS AND SHORTNESS OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187348 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME SET GJS ALERE SAN DIEGO, INC 100071 299626

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization ORAL ANTICOAGULANTS COUMADIN