BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1012654 · Received March 11, 2008

    Report

    Report Number
    2954730-2008-00114
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 11, 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: SEE SCANNED TABLE. PER INTERNAL PROCEDURE, TR 0150, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. PER EMAIL, THE PATIENT WITH FOURTH SET OF DATA WAS ADMITTED TO THE ER. THIS IS ADVERSE EVENT CASE. PRODUCTS WILL BE TESTED WHEN RETURNED. PER EMAIL, ALL PATIENTS WERE IN STABLE CONDITION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: SEE SCANNED TABLE. THE PATIENT WITH FOURTH SET OF DATA WAS ADMITTED TO THE ER. THIS IS ADVERSE EVENT CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ 070325

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization