BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2090935 · Received May 2, 2011

    Report

    Report Number
    2027969-2011-00973
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. PT'S THERAPEUTIC RANGE: 2-3 INR. ON (B)(6) 2011, PT NOTICED BLOOD IN HIS URINE AND WENT TO THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 243396

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other