BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2903986 · Received January 3, 2013

    Report

    Report Number
    2027969-2013-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 3, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    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. RESULTS AS FOLLOWS:" DATE: (B)(6) 2012, INRATIO: 6.2, LAB: 3.2. TIME ELAPSED BETWEEN EACH METHOD OF TESTING IS LESS THAN ONE HOUR. PT'S THERAPEUTIC RANGE IS 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3599 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 275255

    Patients

    Seq Age Sex Outcome Treatment
    1 POTASSIUM| METFORMIN| WARFARIN| MELOXICAM| BENADRYL