BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1780878 · Received July 30, 2010

    Report

    Report Number
    2027969-2010-01094
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    NURSE REPORTED DISCREPANT RESULTS FOR PT #1: (B)(6)2010, INRATIO: 2.0, LAB: --; (B)(6)2010, 1.6, 10.5. PT BLEEDING AND WAS ADMINISTERED VITAMIN K. PT FOLLOWED UP ON (B)(6)2010 AND HAD NORMAL LABS EXCEPT FOR ELEVATED DIGOXIN LEVEL AND THYROID WAS OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 232170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other