BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2123196 · Received June 10, 2011

    Report

    Report Number
    2027969-2011-01310
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 5, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER: PATIENT HAD BEEN TAKEN OFF OF COUMADIN ON (B)(6) 2011 FOR A DENTAL PROCEDURE AND THEN PLACED BACK ON IT (B)(6) 2011. PATIENT WAS EXPERIENCING RECTAL BLEEDING DUE TO A COLON TEAR ON (B)(6) 2011. THERAPEUTIC RANGE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 251112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other