BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3172299 · Received June 5, 2013

    Report

    Report Number
    2027969-2013-00447
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGES DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 3.0, DOCTOR'S POC: 1.9. TESTS WERE DONE ONE AFTER THE OTHER. THERAPEUTIC RANGE: 2.0-2.5. PATIENT SELF TESTER'S COUMADIN DOSE WAS DECREASED IMMEDIATELY PRECEDING HOSPITALIZATION ON (B)(6) 2013. PATIENT WAS HOSPITALIZED BETWEEN (B)(6) 2013 FOR TIA; CLOT. CALLER COULD NOT PROVIDE SPECIFIC INFORMATION REGARDING IF THE SAME FINGER STICK WAS USED ON BOTH METERS BUT DID CALL BACK TO NOTE THAT THE DOCTOR'S METER WAS ALSO ON INRATIO METER AND THE SAME STRIP LOT WAS USED IN BOTH INSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249237 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 301624

    Patients

    Seq Age Sex Outcome Treatment
    1 SIMVASTATIN| COUMADIN| METOPROLOL| LOVENOX