BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2800743 · Received October 17, 2012

    Report

    Report Number
    2027969-2012-01522
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AS FOLLOWS:" DATE: (B)(6) 2012; INRATIO2: 2.1; LAB: 1.7. TIME ELAPSED BETWEEN EACH METHOD OF TESTING IS ONE HOUR. PT'S THERAPEUTIC RANGE IS 2.0-3.0. PT WAS HOSPITALIZED ON (B)(6) 2012 FOR INTERNAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 NG

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O