BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1163624 · Received September 2, 2008

    Report

    Report Number
    2954730-2008-00533
    Event Type
    Malfunction
    Date Received
    September 2, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 29, 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 RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: 07 AUG: 4.7, 07 AUG: 2.5, AVERAGE: 3.6, STD: 1.56, %CV: 43.21. %CV THE VALUE IS GREATER THAN 20% THE CRITERION IS NOT MET. % CV THE VALUE IS GREATER THAN 20% WHICH IS 43.21% AS PER INTERNAL PROCEDURE, THE PRODUCT WILL BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH REPEATED TEST RESULTS. THE TEST RESULTS FOR THE REPEATED INRATIO IS AS FOLLOWS: 07 AUG: 4.7, 07 AUG: 2.5.

    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