BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2256961 · Received September 14, 2011

    Report

    Report Number
    2027969-2011-01964
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 17, 2011
    Report Date
    September 14, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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) 2011, INRATIO: 4.1, LAB: 16.2, DATE: (B)(6) 2011, INRATIO: 3.9. ON (B)(6) 2011 OR (B)(6) 2011 PT WAS TAKEN TO THE ER: NOT FEELING WELL; COUGHING UP BLOOD AND VOMITING. NO LAB WORK WAS DONE AT THAT TIME BUT PT WAS INSTRUCTED BY PHYSICIAN TO STOP COUMADIN DOSE SINCE THE ER VISIT. RECEIVED VITAMIN K TREATMENT TODAY ((B)(6) 2011) BECAUSE OF 16.2 LAB RESULT. CALLER CONFIRMS LAB INR RESULT IS "16.2." THERAPEUTIC RANGE 2.0-3.0. ON (B)(6) HEMOGLOBIN COUNT 6.0; CALLER THINKS PT MAY NOW BE ANEMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 253024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other