BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1163103 · Received September 16, 2008

    Report

    Report Number
    2954730-2008-00556
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    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 COMPLIANT WAS FILED: THE ID 1, 2, AND 3 ARE WITHIN THE CONFIDENT LIMITS AS REV.2. PROD WILL NOT BE INVESTIGATED. PT CHANGE OF DOSAGE OF MEDICATION AND THIS EVENT IS CONSIDERED AS ADVERSE EVENT.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008; ID: 1; INRATIO: 1.7; LAB: 3.3. DATE: 2008; ID: 2; INRATIO: 2.7; LAB: 3.2. DATE: 2008; ID: 3; INRATIO: 2.6; LAB: 2.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100004 080015A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI