BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 843989 · Received April 26, 2007

    Report

    Report Number
    2954730-2007-00200
    Event Type
    Injury
    Date Received
    April 26, 2007
    Date of Event
    April 10, 2007
    Report Date
    April 20, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070027: FIRST TEST INR = 1.1 (4/2007). SECOND TEST INR = 7.0 (TWO DAYS LATER). MEAN = 4.05; SD = 4.17; %CV = 100.03%. THE %CV IS GREATER THAN 20%. HOWEVER, THE TIME INTERVAL BETWEEN TESTS IS 48 HOURS. PER INTERNAL PROCEDURE, 3 HOURS BETWEEN TESTS IS RECOMMENDED TO BE VALID. HOWEVER, DUE TO THE FACT THE PATIENT WAS HOSPITALIZED AND A SURGICAL PROCEDURE WAS PERFORMED, THIS COMPLAINT QUALIFIES AS AN ADVERSE EVENT. AN INVESTIGATION IS REQUIRED. OTHER RESULTS: 02/2007: 3.2, ONE WEEK LATER: 3.0, 03/2007: 3.8, 3/11/07: 3.3, EIGHT DAYS LATER: 4.5, ONE WEEK LATER: 2.8, THE FOLLOWING MONTH: 1.1. PER INTERNAL PROCEDURE, 3 HOURS BETWEEN TESTS IS RECOMMENDED TO BE VALID. TESTING TIME INTERVAL APPEARS TO BE A FEW DAYS APART, MAKING THESE TEST RESULTS INVALID.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 1.1 (4/2007). SECOND TEST INR = 7.0 (TWO DAYS LATER). THE PATIENT WAS HOSPITALIZED AND A SURGICAL PROCEDURE WAS PERFORMED, THIS COMPLAINT QUALIFIES AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 0700027

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O