BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1780762 · Received July 26, 2010

    Report

    Report Number
    2027969-2010-01049
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6)2010, INR: 5.3, 5.8. PT'S COUMADIN DOSE WAS DECREASED. NO LAB CONFIRMATION TEST PERFORMED. CUSTOMER ALSO REPORTED MULTIPLE NES ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 224380

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention