BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1975688 · Received January 24, 2011

    Report

    Report Number
    2027969-2011-00165
    Event Type
    Other
    Date Received
    January 24, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 24, 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 COMPARED WITH THE LAB. COUMADIN DOSE CHANGED BASED ON LAB RESULT. CUSTOMER TESTED WITH NEW STRIP LOT (234130). PT'S THERAPEUTIC RANGE = 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 233029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other