BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1130003 · Received August 19, 2008

    Report

    Report Number
    2954730-2008-00499
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    July 21, 2008
    Report Date
    August 11, 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: SEE SCANNED TABLE. TEST #1, TEST#2, TEST#3 AND TEST#4 ARE WITH CONFIDENT LIMITS. NO INVESTIGATION IS NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: SEE SCANNED TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100071 NP

    Patients

    Seq Age Sex Outcome Treatment
    1 NI