BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2091461 · Received May 5, 2011

    Report

    Report Number
    2027969-2011-01001
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 5, 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
    PA, 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: 4.8, LAB: 4.0. TESTS DONE WITHIN ONE HOUR. PATIENT RECEIVED NEW STRIPS AND TESTED BOTH STRIP LOTS: DATE: NG, OLD STRIP: 1.8, NEW STRIP: 1.6, DATE: (B)(6) 2011, OLD STRIP: 2.9, NEW STRIP: 2.7, LAB: 2.5. (OLD STRIP LOT #251112). PATIENT SELF TESTER STARTED TESTING ON METER ABOUT 3 WEEKS AGO. THIS IS THE FIRST TIME SHE HAS TESTED HER METER AGAINST THE LAB. PATIENT HAS NOTICED SOME BRUISING, NOT SURE IF IT WAS FROM HITTING HERSELF AGAINST SOMETHING, STATED THAT IT IS NOT SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 251112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other