BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1913777 · Received November 23, 2010

    Report

    Report Number
    2027969-2010-02050
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    September 2, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. (ALL CORRELATIONS DONE WITHIN 5 MINUTES OF EACH OTHER). THERAPEUTIC RANGE: 2.0 TO 3.0. PT STATED HE LIVES AT A 9000 FT. ELEVATION; HOWEVER, TESTS WERE DONE AT CLINIC AT 5000 FT ELEVATION. PT RECEIVED NEW STRIPS AND TESTED ON NOV 4TH INR =3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 233708

    Patients

    Seq Age Sex Outcome Treatment
    1