BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1001346 · Received February 19, 2008

    Report

    Report Number
    2954730-2008-00070
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 14, 2008
    Manufacturer
    HEMOSENSE SJ
    Product Code
    JPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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: IN 2008, INRATIO: 2.0, LAB >5.0, MEAN: CANNOT BE DETERMINED, CONFIDENCE LIMITS: CANNOT BE DETERMINED. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE MEAN AND CONFIDENCE LIMITS CANNOT BE DETERMINED BECAUSE THE LAB VALUE IS >5.0. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: IN 2008, INRATIO: 2.0, LAB: >5.0. THIS CASE QUALIFIES AS AN ADVERSE EVENT. PATIENT'S DOSE WAS ADJUSTED. ADVERSE EVENT FOLLOW UP: PATIENT IS NOW IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ KIT, SELF-TEST, ENGLISH 070382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention