BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2063058 · Received April 11, 2011

    Report

    Report Number
    2027969-2011-00760
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 3, 2010
    Report Date
    April 11, 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

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011; INRATIO2: 1.5; LAB: 2.3. DATE: (B)(6) 2011; INRATIO2: 3.6; LAB: 3.1. ON (B)(6) 2011 RESULTS DONE ABOUT 3 HOURS APART. TARGET THERAPEUTIC RANGE 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243699

    Patients

    Seq Age Sex Outcome Treatment
    1