BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1171947 · Received September 19, 2008

    Report

    Report Number
    2954730-2008-00562
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    June 13, 2008
    Report Date
    September 17, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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: 2008; INRATIO: 5.0; LAB: 3.68; MEAN: 4.34; CONFIDENT LIMITS: 2.5-6.5; DATE: TWO MONTHS LATER; INRATIO: 5.0; LAB: 3.32; MEAN: 4.16; CONFIDENT LIMITS: 2.4-6.1. AS PER INTERNAL PROCEDURE TR#0150 REV.2, THE INRATIO AND LAB VALUE ARE WITHIN THE CONFIDENT LIMIT, ALSO THE PATIENT REPEATED THE TEST IN 2008. 12-JUN: 5.6; SAME DAY: 3.9; AVERAGE: 4.75; STDEV: 1.20; %CV: 25.31. AS PER INTERNAL PROCEDURE TR#0150 REV. 2 (SECTION 8.2), THE ACCEPTANCE CRITERION FOR IMPRECISION IS A %CV 20 OR LESS. IF IT IS GREATER THAN 20% THE CRITERION IS NOT MET. HERE IS THE %CV IS GREATER THAN 20%, WHICH IS 25.31 THE CRITERION IS NOT MET. PRODUCT WILL BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008; INRATIO: 5.0; LAB: 3.68; DATE: TWO MONTHS LATER; INRATIO: 5.0; LAB: 3.32. THE CALLER ALSO DISCREPANT RESULTS WHEN REPEATED THE TEST WITH INRATIO METER. THE RESULTS ARE AS FOLLOWS: 2008 - 5.6; AND SAME DATE 3.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100007 080076

    Patients

    Seq Age Sex Outcome Treatment
    1 NI