BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1173455 · Received September 23, 2008

    Report

    Report Number
    2954730-2008-00568
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 19, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    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: DATE: 2008; INRATIO: 6.3; LAB: 9.2; MEAN: 7.75; CONFIDENT LIMITS: NOT WITHIN THE CONFIDENT LIMIT. REV. 2 SECTION 10.1 THE MEAN IS GREATER THAN 5 WHICH IS 7.75 AND DIFFERENCE IN INR'S IS GREATER THAN 2.2 WHICH 2.9. ACCEPTANCE RANGE IS INACCURATE. THE PRODUCT WILL BE INVESTIGATED. PT COUMADIN WAS HELD. THIS EVENT IS AN ADVERSE EVENT. ALSO PT IS NOW WITHIN THE NORMAL RANGE 3.1.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008; INRATIO: 6.3; LAB: 9.2.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI