BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1941336 · Received December 17, 2010

    Report

    Report Number
    2027969-2010-02196
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 17, 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
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: "LAST WEEK", LAB: 5.2. DATE: (B)(6) 2010, INRATIO: 1.3. AFTER 5.2 RESULT LAST WEEK, THE PT'S COUMADIN DOSE WAS WITHHELD FOR 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other