BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2102608 · Received May 20, 2011

    Report

    Report Number
    2027969-2011-01118
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ALERE SAN DIEGO INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 POC AND LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 3.0, POC METER: 2.7, LAB: 2.81, (B)(6) 2011, 4.6, 3.5, (B)(6) 2011, 3.1, 2.7. DOCTOR SET PT'S THERAPEUTIC RANGE:2-3. CARDIOLOGIST SET THERAPEUTIC RANGE: 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC. 100071 243103

    Patients

    Seq Age Sex Outcome Treatment
    1