BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2042201 · Received March 28, 2011

    Report

    Report Number
    2027969-2011-00625
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 2.4, LAB: 1.7. PT'S SON REPORTS THAT THE PT HAD AN EPISODE OF ELEVATED INR IN (B)(6) WITH BLEEDING/BRUISING. NO DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other