BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1163626 · Received September 2, 2008

    Report

    Report Number
    2954730-2008-00535
    Event Type
    Malfunction
    Date Received
    September 2, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 28, 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 AND LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE ID INRATIO LAB MEAN. CONFIDENT LIMIT. 2008, PATIENT 1- 5.5; 6.2; 5.85 NOT WITHIN THE CONFIDENT LIMIT. 2008 PATIENT 2- 0.9; 1.9 1.4 ;1.1-1.9. THE PATIENT 1 WITH INRATIO AND LAB VALUE BOTH THE VALUES ARE GREATER THAN 5.0. SO THEY ARE NOT WITHIN THE CONFIDENT LIMIT AS PER OUR INTERNAL PROCEDURE. PRODUCT WILL BE INVESTIGATED. FOR PATIENT #2 THE INRATION VALUE IS NOT IN CONFIDENT LIMIT AND THE LAB VALUE IS WITHIN CONFIDENT LIMIT. ALSO AS PER INTERNAL PROCEDURE SECTION 8.3.3 IF THE TIME ELAPSED THREE HOURS THERE IS HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. PRODUCT WILL BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH LAB RESULTS REPORTED AS FOLLOWS: DATE 2008; ID PATIENT 1; INRATIO 5.5; LAB: 6.2. DATE 2008; ID PT 2; INRATIO 0.9; LAB 1.9.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI