BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1193518 · Received October 8, 2008

    Report

    Report Number
    2954730-2008-00596
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 7, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    PMA / PMN Number
    NI
    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 PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: 2008: 1, SAME DAY: 1.1, AVERAGE: 1.05, STDEV: 0.07, %CV 6.73. THE ACCEPTANCE CRITERION IS 20% OR LESS AS PER INTERNAL PROCEDURE. THE PRODUCT WILL NOT BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN REPEATED THE TEST WITH INRATIO METERS. THE RESULTS ARE AS FOLLOWS: 2008: 1, SAME DAY: 1.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100004 080001A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI