BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 1759147 · Received June 29, 2010

    Report

    Report Number
    2027969-2010-00847
    Event Type
    Injury
    Date Received
    June 29, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS. PATIENTS DOSE HAS BEEN DECREASED EACH WEEK. RESULT FROM (B)(6)2010 WAS TAKEN USING A NEW STRIP LOT (#233708).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 218917

    Patients

    Seq Age Sex Outcome Treatment
    1 Other