BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1020736 · Received March 27, 2008

    Report

    Report Number
    2954730-2008-00147
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 25, 2008
    Manufacturer
    HEMOSENSE SJ
    Product Code
    JPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2007; INRATIO: 1.6; LAB: 5.9; MEAN: 3.75; CONFIDENCE LIMITS: 2.2-5.3. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES ARE OUTSIDE THE CONFIDENCE LIMITS FOR INR TESTING. PER TEXT "THE PT'S COUMADIN DOSE WAS HELD FOR A FEW DAYS AND WAS STABLE AFTER". THIS IS ADVERSE EVENT CASE. PRODUCTS WILL BE TESTED WHEN RETURNED. PER TEXT "PT IN QUESTION WAS ALREADY RELEASED FROM THEIR NURSING FACILITY".

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2007; INRATIO: 1.6; LAB: 5.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ 070351

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention