BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1052191 · Received May 20, 2008

    Report

    Report Number
    2954730-2008-00391
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 20, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Adverse Event
    Yes
    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: 2008, INRATIO: 2.1, LAB: 2.3, MEAN: 2.2, CONFIDENCE LIMITS: 1.4-3.1. DATE: 2008, INRATIO: 2.0, LAB: 7.9, MEAN: 5.0, CONFIDENCE LIMITS: 2.8-7.2. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE 1ST DATA SET, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. BOTH INRATIO AND LAB VALUES ARE NOT WITHIN THE CONFIDENCE LIMITS FOR INR TESTING FOR THE 2ND DATA SET. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING REQUIRED AT THIS TIME. ON 2008, PT WAS GREATER THAN 100 DRAWN BY LAB. THE FOLLOWING MONTH, SAME PT DONE BY LAB GIVEN VITAMIN K. THE NEXT DAY, SAME PT TESTED WITH INRATIO 2.1 AND LAB WAS 2.3.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE 2008, INRATIO: 2.1, LAB: 2.3. DATE 2008, INRATIO: 2.0, LAB: 7.9. THIS CASE QUALIFIES AS AN ADVERSE EVENT. PT WAS ADMITTED INTO THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070510

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R