BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1770344 · Received July 16, 2010

    Report

    Report Number
    2027969-2010-00978
    Event Type
    Other
    Date Received
    July 16, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PER CUSTOMER, 2 PTS EXHIBITED IMPRECISION WHEN TEST REPEATED. ONE PT'S RESULT WAS LOWER THAN EXPECTED AND LOWER WHEN COMPARED TO LAB RESULT. ALL PTS TESTED USING SAME METER AND STRIP LOT. THERAPEUTIC RANGE = 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 232888

    Patients

    Seq Age Sex Outcome Treatment
    1 Other