BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2230937 · Received July 20, 2011

    Report

    Report Number
    2027969-2011-01592
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    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 RESULTS USING THE INRATIO2 METER. RESULTS AS FOLLOWS: THE FOLLOWING RESULTS HAVE OCCURRED OVER THE "PAST FEW WEEKS": 3.3, 1.3, 1.8, 4.2, 1.4, 3.3, 1.3, DATE: UNK, INRATIO: 1.4, LAB: 1.9. TAKES HER COUMADIN AT 10 PM EVERY NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 NG

    Patients

    Seq Age Sex Outcome Treatment
    1