BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1000485 · Received February 21, 2008

    Report

    Report Number
    2954730-2008-00081
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 25, 2008
    Report Date
    February 20, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: PER INTERNAL PROCEDURE, THE MEAN OF THE RATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST 2 SETS OF DATA, THE CONFIDENCE LIMITS CANNOT BE DETERMINED. PER EMAIL TEXT "PATIENT HAS TAKEN HIGHER DOSE DUE TO INRATIO RESULTS." THIS IS ADVERSE EVENT CASE. PRODUCTS WILL BE TESTED WHEN RETURNED. FOR THE REST OF DATA SETS, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. KIT, MULTI, ANGLO SAXIN LATIN 070014

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention