BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1193122 · Received October 6, 2008

    Report

    Report Number
    2954730-2008-00589
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 3, 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 FLED: THE CALLER ALSO ALLEGED THAT HE CALLED DISCREPANT RESULTS WHEN REPEATED THE INRATIO METER. AS PER INTERNAL PROCEDURE REV. 2 FOR FIRST TEST INRATIO VALUE IS NOT WITHIN THE CONFIDENT LIMIT. FOR THE TEST 2 AND 3 THE INRATIO AND LAB VALUES ARE WITHIN CONFIDENT LIMIT. PRODUCT WILL BE INVESTIGATED. AS PER INTERNAL PROCEDURE REV. 2 SECTION 8.3.3 IF THE TIME ELAPSED EXCEEDS THREE HOURS THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THE RESULTS AND CALCULATION ARE AS FOLLOWS: 2008: 1, 2008: 1.5, 2008: 1.9, 2008: 2.2, 2008: 2.8, AVERAGE: 1.88, STDEV 0.68: %CV: 36.35. AS PER INTERNAL PROCEDURE REV. 2 THE %CV IS GREATER THAN 20%. CRITERION IS NOT MET. PRODUCT WILL BE INVESTIGATED. MD 2008.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS. THE CALLER ALSO ALLEGED DISCREPANT RESULTS WHEN REPEATED THE TEST WITH SAME INRATIO METER. THE RESULTS ARE AS FOLLOWS: 2008: 1, 2008: 1.5, 2008: 1.9, 2008: 2.2, 2008: 2.8.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI