BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1511467 · Received October 12, 2009

    Report

    Report Number
    2027969-2009-00927
    Event Type
    Injury
    Date Received
    October 12, 2009
    Date of Event
    September 14, 2009
    Report Date
    October 12, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARTED WITH THE LAB. RESULTS AS FOLLOWS:" IN 2009 - 10:10 AM INRATIO: 2.4; 11:30 AM LAB: 6.0; 1:30 PM INRATIO: 4.9. PT IN HOSPITAL GETTING VITAMIN K. THE FOLLOWING DAY - INRATIO: 2.2 AND LAB: 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0100267 211583P

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention