BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1923631 · Received December 10, 2010

    Report

    Report Number
    2027969-2010-02151
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 11, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    072727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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) 2010, INRATIO: 0.7, LAB: NG. DATE: (B)(6) 2010, INRATIO: >7.5 (STRIP LOT #233421), LAB: NG; INRATIO: >7.5 (STRIP LOT #234527), LAB: NG. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR. ON (B)(6) 2010, PT'S COUMADIN DOSE WAS INCREASED FROM 2.5 MG/DAY TO 5MG/DAY AND 7.5 MG ON SUNDAYS BY HER PHYSICIAN. ON (B)(6) 2010, PT EXPERIENCED A LITTLE BIT OF BLEEDING FROM THE RIGHT NOSTRIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 200457 NG

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other| R