BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1308678 · Received February 6, 2009

    Report

    Report Number
    2954730-2009-00040
    Event Type
    Injury
    Date Received
    February 6, 2009
    Date of Event
    January 19, 2009
    Report Date
    February 6, 2009
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: EARLY 2009. INRATIO: 1.6. LAB: 4.6. THIS IS CONSIDERED AN ADVERSE EVENT BECAUSE PATIENT'S COUMADIN WAS WITHHELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100004

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention