BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1130005 · Received August 19, 2008

    Report

    Report Number
    2954730-2008-00501
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    July 21, 2008
    Report Date
    August 14, 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 RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INR 1 AND 4 ARE NOT WITHIN THE CONFIDENT LIMIT AS PER THE INTERNAL PROCEDURE (REV.2) . AT 2, 3, 5 AND 6 ARE WITHIN THE CONFIDENT LIMITS AS PER THE INTERNAL PROCEDURE (REV .2). THE PRODUCT WILL BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE INC. 0100004 070533A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI