BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2982969 · Received February 22, 2013

    Report

    Report Number
    2027969-2013-00163
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT IS A TODDLER. PATIENT'S MOTHER CALLED ALLEGING PRECISION ISSUES. INRATIO 4.0, LAB 6.5. TESTS PERFORMED IMMEDIATELY AFTER ONE ANOTHER. PATIENT'S THERAPEUTIC RANGE 2.5 - 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77853 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 299628

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN