BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2230949 · Received July 20, 2011

    Report

    Report Number
    2027969-2011-01588
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 8, 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
    CA, 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: 3.3, LAB: 1.9. DATE: (B)(6) 2011, INRATIO: 3.9, LAB: 2.3. TESTING APPROX 12 HOURS APART. TESTED WITHIN ONE HOUR. TARGET INR IS 2.0-2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 248203

    Patients

    Seq Age Sex Outcome Treatment
    1