BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1193118 · Received October 6, 2008

    Report

    Report Number
    2954730-2008-00592
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 26, 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: DATE: 2005, ID: 1, INRATIO: 4.5, LAB: 3.4, MEAN: 3.95, CONFIDENT LIMITS: 2.3-5.7, DATE: 2005, ID: 2, INRATIO: 4.6, LAB: 3.5, MEAN: 4.05, CONFIDENT LIMITS: 2.4-6.1. FOR THE ID #1 AND 2 THE INRATIO VALUE AND LAB VALUES ARE WITHIN THE CONFIDENT LIMIT AS PER INTERNAL PROCEDURE TR#0150 REV.2. AS PER INTERNAL PROCEDURE TR#0150, REV .2 IF THE INRATIO VALUE AND LAB VALUES ARE WITHIN THE CONFIDENT LIMIT PRODUCT WON'T BE TESTED. SINCE THE PRODUCT IS EXPECTED TO BE RETURNED BY THE CUSTOMER IT WILL BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2005, ID: 1, INRATIO: 4.5, LAB: 3.4, DATE: 2005, ID: 2, INRATIO: 4.6, LAB: 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTROMBIN TIME TEST JPA HEMOSENSE, INC. 0100007 NP

    Patients

    Seq Age Sex Outcome Treatment
    1 NI