BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1100822 · Received August 6, 2008

    Report

    Report Number
    2954730-2008-00491
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 5, 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: 2.8, LAB: 8.0, MEAN: 5.40, CONFIDENT LIMITS: NO CONFIDENT LIMIT CAN BE DETERMINED. DATE: THE FOLLOWING MONTH, INRATIO: 4.2, LAB: 2.0, MEAN: 3.1, CONFIDENT LIMITS: 1.9-4.6. ORIGINAL DATE RESULTS, THE CONFIDENT LIMIT CANNOT BE DETERMINED AS PER INTERNAL PROCEDURE. THE FOLLOWING MONTH RESULTS, THE CONFIDENT LIMITS WERE WITHIN THE ACCURACY LIMIT AS PER PROCEDURE. COUMADIN WAS HELD BACK AND THIS ADVERSE EVENT CASE. INVESTIGATION IS REQUIRED. THE DISCREPANT PRODUCT WILL BE INVESTIGATED UPON RETURN.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008. INRATIO: 2.8. LAB: 8.0. DATE: 04 AUG. INRATIO: 4.2. LAB: 2.0. PATIENTS COUMADIN WAS HELD BACK AND THIS IS AN ADVERSE EVENT.

    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