BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2071742 · Received April 13, 2011

    Report

    Report Number
    2027969-2011-00892
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO2 METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 5.5. DATE: (B)(6) 2011, INRATIO2: 1.7. PATIENT'S THERAPEUTIC RANGE: 2.5-3.5 INR. ON (B)(6) 2011, PHYSICIAN DECREASED PATIENT'S COUMADIN DOSE DUE TO THE HIGH INRATIO INR RESULT. THE NEXT DAY, THE PHYSICIAN ADVISED PATIENT THAT HER INR SHOULD NOT HAVE DECREASED THAT QUICKLY FROM THE DOSE CHANGE. ON (B)(6) 2011, PATIENT TESTED ON HER PHYSICIAN'S POINT-OF-CARE METER AND OBTAINED A RESULT OF 2.6, WHICH WAS WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other