BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2934457 · Received January 11, 2013

    Report

    Report Number
    2027969-2013-00025
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 11, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    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 ALLEGING DISCREPANT LOW RESULTS USING ONE METER, ONE LOT. INRATIO: 2.2, LAB: 7.2, TIME BETWEEN TESTING: 2 AND A HALF HOURS. PT'S THERAPEUTIC RANGE: 3.5 - 4.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19333 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 291547

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| AUGMENTIN