BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1912365 · Received November 23, 2010

    Report

    Report Number
    2027969-2010-02052
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    LOW RESULTS WITH NEW STRIPS - NO FURTHER LAB COMPARISON YET. PT HAD INR OF 1.8 ON METER. DOCTOR RECENTLY RAISED DOSE OF COUMADIN TO 10 MG DAILY BASED ON LOW METER RESULTS. PT HAS NOTICED THAT SHE BRUISES MORE EASILY LATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243699

    Patients

    Seq Age Sex Outcome Treatment
    1 Other