BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2903403 · Received December 14, 2012

    Report

    Report Number
    2027969-2012-01708
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. RESULTS AS FOLLOWS:" DATE (B)(6) 2012, INRATIO2 2.0, LAB 8.0. TIME ELAPSED BETWEEN EACH METHOD OF TESTING IS THIRTY MINUTES. PT'S THERAPEUTIC RANGE IS 2.0 - 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 281272

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN