BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1313025 · Received February 13, 2009

    Report

    Report Number
    2027969-2009-00014
    Event Type
    Injury
    Date Received
    February 13, 2009
    Date of Event
    January 21, 2009
    Report Date
    February 12, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    IN EARLY 2009, CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: 2008; INRATIO: 3.3; LAB: 6.5. PATIENT'S COUMADIN WAS HELD, THEN RETESTED WAS OK. THIS METER WAS NOT USED SINCE ISSUE HAPPENED. THIS IS CONSIDERED AN ADVERSE EVENT BECAUSE PATIENT'S COUMADIN WAS HELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0100004

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention