BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1843843 · Received September 20, 2010

    Report

    Report Number
    2027969-2010-01510
    Event Type
    Other
    Date Received
    September 20, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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) 2010, INRATIO: >7.5. >7.5, LAB: 6.1. LAB DRAWN DONE WITHIN ONE HOUR OF FINGERSTICK. PT'S COUMADIN WILL BE DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 227285

    Patients

    Seq Age Sex Outcome Treatment
    1 Other