BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1130008 · Received August 19, 2008

    Report

    Report Number
    2954730-2008-00505
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 13, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULT (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2008; INRATIO: 5.2; LAB: 3.2; MEAN: 4.2; CONFIDENT LIMITS: 2.4-6.1. THE MEAN FOR INRATIO AND LAB MEAN ARE WITHIN THE CONFIDENT LIMITS AS PER INTERNAL PROCEDURE TR#0150 (REV.2). NO INVESTIGATION IS NEEDED AS PER INTERNAL PROCEDURE TR#0150 (REV.2).

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2008; INRATIO: 5.2; LAB: 3.2.

    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