BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2111834 · Received May 26, 2011

    Report

    Report Number
    2027969-2011-01180
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    March 16, 2011
    Report Date
    May 26, 2011
    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

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 3.8, LAB: 2.7. TESTS WERE DONE WITHIN AN HOUR OF EACH OTHER. PATIENT SELF TESTER CALLED IN THE METER RESULT AND HER DOCTOR CHANGED HER DOSE FOR THAT NIGHT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other