BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 715600 · Received May 10, 2006

    Report

    Report Number
    2954730-2006-00258
    Event Type
    Malfunction
    Date Received
    May 10, 2006
    Date of Event
    April 27, 2006
    Report Date
    May 4, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB FOR LOT NUMBER 050749. RESULTS REPORTED AS FOLLOWS: DATE 04/28/06 INRATIO 3.8 LAB 3.22 THE CALLER ALLEGED IMPRECISION TEST RSULTS WITH INRATIO FOR LOT NUMBER 050664. REPORTED RESULTS AS FOLLOWS: 03/30/06 FIRST TESTINR + 3.9 SECOND TEST INR = 3.1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 050664

    Patients

    Seq Age Sex Outcome Treatment
    1 *