BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 3201951 · Received June 27, 2013

    Report

    Report Number
    2027969-2013-00521
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    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 PRECISION RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 3.0, INRATIO: 1.3, INRATIO: 1.2. TIME BETWEEN TESTING WAS REPORTED AS WITHIN MINUTES OF EACH OTHER. PT'S THERAPEUTIC RANGE IS 2.0 -3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293192 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 310820

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN