BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1193515 · Received October 8, 2008

    Report

    Report Number
    2954730-2008-00595
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 23, 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) WHEN REPEATED IN RATIO TEST WITH DIFFERENT HEMOSENSE METERS. THE RESULTS ARE PROVIDED BY THE END-USER AT TIME COMPLAINT WAS FILED: CLINIC: 4.1, INRATIO (RT): 5.1, INRATIO (LT): 5.8, DIFF LOT: 5.3, AVERAGE: 5.08, STDEV: 0.71, %CV: 14.06. AS PER INTERNAL PROCEDURE IF THE INRATIO VALUE % CV IS LESS THAN 20%, THE CRITERION IS MET. HERE THE %CV IS 14.06% SO THE CRITERION IS MET. THE PRODUCT WILL NOT BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN REPEATED THE TEST WITH TWO DIFFERENT INRATIO METERS. THE RESULTS ARE AS FOLLOWS: CLINIC: 4.1, INRATIO (RT): 5.1, INRATIO (LT): 5.8, DIFF LOT: 5.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100071 070761B

    Patients

    Seq Age Sex Outcome Treatment
    1 NI