BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1193120 · Received October 6, 2008

    Report

    Report Number
    2954730-2008-00588
    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 IN THE INRATIO METER. THE RESULT PROVIDED BY THE CALLER IS AS FOLLOWS: SEE SCANNED TABLE. AS PER INTERNAL PROCEDURE, THE ACCEPTANCE CRITERION FOR IMPRECISION IS A 20% OR LESS IN THE CV. THE %CV FOR THIS EVENT IS 19.92 WHICH IS LESS THEN 20% CRITERION IS MET, AND 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: 2008 - 2.8, 2.2, 1.9.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI