BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1193123 · Received October 6, 2008

    Report

    Report Number
    2954730-2008-00590
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 3, 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 REPEATED TEST WITH TWO DIFFERENT HEMOSENSE METERS. THE RESULTS AND CALCULATIONS ARE AS FOLLOWS: DATE: 3.5; 2.1, AVERAGE: 2.8, STDEV: 0.99, %CV: 35.36. AS PER INTERNAL PROCEDURE, REV. 2 IF THE VALUE IS GREATER THAN 20% THE CRITERION IS NOT. PRODUCT WILL BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH LAB RESULTS REPORTED AS FOLLOWS: 3.5; 2.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100007 NP

    Patients

    Seq Age Sex Outcome Treatment
    1 NI