BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 1984494 · Received February 1, 2011

    Report

    Report Number
    2027969-2011-00222
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 29, 2011
    Report Date
    February 1, 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
    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. ALL TESTING OCCURRED WITHIN ONE HOUR OF ONE ANOTHER. PATIENT SELF TESTER TESTS EVERY TWO WEEKS. PER CUSTOMER, PATIENT'S RESULTS ARE OFTEN ERRATIC FOR UNKNOWN CAUSE. PATIENT WAS TREATED WITH VITAMIN K AND SENT HOME. OFF COUMADIN DOSE FOR 3 DAYS. BACK ON COUMADIN ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 233708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other