BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1881682 · Received October 18, 2010

    Report

    Report Number
    2027969-2010-01749
    Event Type
    Other
    Date Received
    October 18, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT RESULTS WITH INRATIO METER COMPARED TO LAB AND A DR'S METER (NOT INRATIO). DATE: (B)(6) 2010, INRATIO: 1.7, LAB: 12.0, MD METER: 8.0. MD READING WAS A FEW HOURS AFTER THE LAB AND INRATIO RESULTS. THE 8.0 IS THE HIGHEST RESULT THE MD METER WILL GIVE. DR HELD COUMADIN DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 235737

    Patients

    Seq Age Sex Outcome Treatment
    1 Other