BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 3017089 · Received March 19, 2013

    Report

    Report Number
    2027969-2013-00223
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 18, 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
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 1.8, LAB: 5.0. THERAPEUTIC RANGE: 2.0-3.0. PATIENT WAS HOSPITALIZED DUE TO SHORTNESS OF BREATHE AND GIVEN VITAMIN K. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113475 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 296409

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R COUMADIN| SOLU - MEDROL FOR SHORTNESS OF BREATH