BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 654353 · Received December 13, 2005

    Report

    Report Number
    2954730-2005-00152
    Event Type
    Malfunction
    Date Received
    December 13, 2005
    Date of Event
    November 1, 2005
    Report Date
    December 12, 2005
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PER TR 0150, THE CALCULATED MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR ARE 2.75, 2.9 AND 3.15 FOR THE THREE SETS OF DATA WITH DISCREPANT RESULTS. THE CONFIDENCE LIMITS FOR THE 2.75 MEAN ARE 1.6- 3.8. THE REPORTED INR VALUES FROM THE COMPLAINT WERE 2.3 AND 3.2. BOTH VALUES ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE NO FURTHER TESTING IS REQUIRED AT THIS TIME. THE CONFIDENCE LIMITS FOR THE 2.9 MEAN ARE 1.8-4.1. THE REPORTED INR VALUES FROM THE COMPLAINT WERE 2.3 AND 3.2 BOTH VALUES ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE NO FURTHER TESTING IS REQUIRED AT THIS TIME. THE CONFIDENCE LIMITS FOR THE 3.15 MEAN ARE 1.9 - 4.3. THE REPORTED INR VALUES FROM THE COMPLAINT WERE 2.3 AND 3.2. BOTH BALUES ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE NO FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE SUSPECT METER EXHIBITED VARIATION IN TEST RESULTS WHEN COMPARED WITH THE LAB. THE FOLLOWING RESULTS WERE REPORTED: INRATIO 2.3, LAB 3.2. IN 2005 THE FOLLOWING RESULTS WERE REPORTED: INRATIO 3.2, LAB 2.6. IN 2005, THE SAME PATIENT WAS TESTED USING TWO DIFFERENT STRIP LOTS: 050051: INRATIO 2.8, LAB 2.8; 050578: INRATIO 3.5, LAB 2.8.

    Description of Event or Problem · 1

    THE SUSPECT METER EXHIBITED VARIATION IN TEST RESULTS WHEN COMPARED WITH THE LAB. THE FOLLOWING RESULTS WERE REPORTED: INRATIO 2.3; LAB 3.2. ON 11/01/05 THE FOLLOWING RESULTS WERE REPORTED: INRATIO 3.2; LAB 2.6. ON 11/09/2005, THE SAME PT WAS TESTED USING TWO DIFFERENT STRIP LOTS: 050051 INRATIO 2.8; LAB 2.8. 050578 INRATIO 3.5; LAB 2.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TEST TIME JPA HEMOSENSE, INC. * 050051

    Patients

    Seq Age Sex Outcome Treatment
    1 *