BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1211111 · Received October 23, 2008

    Report

    Report Number
    2954730-2008-00618
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 22, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2008, INRATIO: 2.4, HOSPITAL: 11.2, MEAN: 6.8, CONFIDENT LIMITS: INACCURATE. AS PER INTERNAL PROCEDURE REV. 2 THE MEAN IS GREATER THAN 5.0 AND DIFFERENCE BETWEEN INR IS > 2.2 IS CONSIDERED AS INACCURATE. PT ATTENDED PRACTICE FEELING VERY UNWELL AND VOMITING AND HEADACHE. PT WAS ADMINISTERED VITAMIN K AND INR WENT DOWN. THIS IS AN ADVERSE EVENT.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008, INRATIO: 2.4, HOSPITAL: 11.2. PT WAS FEELING UNWELL AND VOMITING AND HEADACHE. PT WAS ADMINISTERED VITAMIN K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100267 0800057A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention