BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1193516 · Received October 8, 2008

    Report

    Report Number
    2954730-2008-00593
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 7, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    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: 5.5, LAB: 3.0, MEAN: 4.25, CONFIDENT LIMITS: 2.8-7.2. AS PER INTERNAL PROCEDURE REV.2 THE INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENT LIMIT. THE PRODUCT WILL NOT BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008, INRATIO: 5.5, LAB: 3.0.

    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