BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2221233 · Received August 15, 2011

    Report

    Report Number
    2027969-2011-01823
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 6.3, LAB: 2.5. PATIENT'S THERAPEUTIC RANGE: 3-4 INR. PATIENT'S COUMADIN DOSE WAS ADJUSTED DUE TO HIGH INRATIO2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 254609

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other