BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 3132502 · Received May 15, 2013

    Report

    Report Number
    2027969-2013-00391
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 15, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 INR RESULT IN COMPARISON TO THE LAB INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013, INRATIO INR: 3.3, LAB INR: 5.2. THE TIME BETWEEN TESTING WAS TWO HOURS. THERAPEUTIC RANGE IS 2.5 - 3.5 FOR THE PT. THE PT WAS INSTRUCTED TO STOP COUMADIN BASED ON THE LAB INR RESULT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216204 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 301624

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention COUMADIN| STARTED PREDNISONE 20MG D TABS DAY| STARTED DOXYCYLINE HYCLATE 100MG 2 TABS DAY