BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1192406 · Received October 6, 2008

    Report

    Report Number
    2954730-2008-00585
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 1, 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 COMPLAINT WAS FILED: DATE: 2008; INRATIO: 5.4; LAB: 1.5; MEAN: 3.45; CONFIDENT LIMITS: 2.0-5.0. AS PER INTERNAL PROCEDURE TR#0150 REV.2, THE INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENT LIMITS. THE INRATIO AND LAB ARE NOT WITHIN THE CONFIDENT LIMIT FOR THIS EVENT. PRODUCT WILL BE INVESTIGATED. PATIENT WAS HELD BACK COUMADIN MEDICATION. THE PT REPEATED THE TEST WITH INRATIO METER. THE RESULTS ARE AS FOLLOWS: FIVE DAYS PRIOR; INRATIO: 7.2; DATE:FIVE DAYS LATER; INRATIO: 5.4; AVERAGE 6.3; STDEV: 1.27; %CV: 20.20. AS PER INTERNAL PROCEDURE TR#0150 REV.2, IF THE VALUE IS GREATER THAN 20%, THE CRITERION IS NOT MET. THE % CV IS GREATER THAN 20 WHICH ARE 20.20 SO THE CRITERION IS NOT MET. PRODUCT WILL BE INVESTIGATED. ALSO THE PT REPEATED THE TEST AFTER 5 DAYS. AS PER INTERNAL PROCEDURE TR#0150 REV.2 SECTION 8.3, IF THE TIME ELAPSED EXCEEDS THREE HOURS, THERE IS HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008; INRATIO: 5.4; LAB: 1.5. THE CALLER ALLEGED REPEATED THE TEST WITH THE METER. THE RESULTS ARE AS FOLLOWS: FIVE DAYS PRIOR; INRATIO: 7.2; FIVE DAYS LATER; INRATIO: 5.4. PATIENT'S COUMADIN WAS HELD BACK AND THIS IS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100071 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention