BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2072969 · Received April 22, 2011

    Report

    Report Number
    2027969-2011-00898
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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) 2011/ INRATIO; 0.9, 1.9; LAB: 2.1. METER INR 2.9 LAST WEEK. THERAPEUTIC RANGE IS 2.0-3.0. PT MENTIONED OBTAINING ONE NES IN BETWEEN THESE RESULTS. CUSTOMER ALSO MENTIONED USING THE SAME FINGER FOR ALL THREE TESTS THIS MORNING; ADVISED OF CORRECT PROCEDURE PER PI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234527

    Patients

    Seq Age Sex Outcome Treatment
    1