BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2982336 · Received February 22, 2013

    Report

    Report Number
    2027969-2013-00164
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 22, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO METER COMPARED TO THE LABORATORY FOR ONE PATIENT. PATIENT#1 CAME INTO THE DOCTOR'S OFFICE DUE TO BRUISING. INRATIO INR=2.1. ALTHOUGH THE PATIENT WAS ADMITTED TO THE HOSPITAL, IT WAS NOT RELATED TO THE INR VALUE; IT WAS DUE TO OTHER ISSUES. THE PATIENT WAS HAVING SHORTNESS OF BREATH AND OTHER ISSUES NOT MENTIONED. WHILE IN THE HOSPITAL, THE LABORATORY THERE WAS UNABLE TO GET AN INR VALUE; THE HOSPITAL SAID THE INR WAS "TOO HIGH TO READ." PATIENT'S THERAPEUTIC RANGE: 2.0 - 3.0. NO OTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77653 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 299625

    Patients

    Seq Age Sex Outcome Treatment
    1 Other COUMADIN