BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1960223 · Received January 5, 2011

    Report

    Report Number
    2027969-2011-00032
    Event Type
    Other
    Date Received
    January 5, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB. LAB DRAW DONE IMMEDIATELY AFTER METER READING ON (B)(6) 2010. COUMADIN DOSE HELD DUE TO LAB RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232167

    Patients

    Seq Age Sex Outcome Treatment
    1 Other