BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1061758 · Received June 13, 2008

    Report

    Report Number
    2954730-2008-00422
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 11, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER. FIRST TEST INR= 2.5, SECOND TEST INR = 4.1. THIRD TEST INR = 3.1. MEAN= 3.23; SD = 0.8; % CV = 25 PERCENT. THE PERCENT CV IS GREATER THAN 20 PERCENT. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCT WILL BE TESTED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: FIRST TEST INR = 2.5, SECOND TEST INR = 4.1, THIRD TEST INR=3.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070650

    Patients

    Seq Age Sex Outcome Treatment
    1