BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1163102 · Received September 16, 2008

    Report

    Report Number
    2954730-2008-00550
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 15, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISCREPANT RESULTS COMPARISON OF INRATIO TEST REPEATED TEST RESULTS PROVIDED BY END USER AT THE TIME COMPLAINT WAS FILED. CALLER DID NOT PROVIDE REAL TIME RESULTS FOR CALCULATE THE CONFIDENT LIMITS AS PER INTERNAL PROCEDURE. PROD WILL BE INVESTIGATED. PT'S DOSAGE OF MEDICATION WAS CHANGED BASED ON THE INRATIO VALUE. INR RATIO 1.4 AND NORMAL TESTING RESULTS IS INR (2.5-3.5).

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS. PT DID NOT GIVE REAL TIME TEST RESULTS BUT JUST MENTIONED THE RANGE. PT DOSAGE OF MEDICATION WAS INCREASED BASED ON INR RESULTS. PT REPORTED INR READINGS ARE AS FOLLOWS: 19 AUG 1.4 AND TESTING RESULTS IS INR (2.5-3.5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100007 NP

    Patients

    Seq Age Sex Outcome Treatment
    1 NI