BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 905411 · Received August 27, 2007

    Report

    Report Number
    2954730-2007-00389
    Event Type
    Malfunction
    Date Received
    August 27, 2007
    Date of Event
    August 3, 2007
    Report Date
    August 22, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    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: 2007, INRATIO: 2.1, LAB: 1.6, MEAN: 1.9, CONFIDENCE LIMITS: 1.3-2.7. DATE: 2007, INRATIO: 1.1, LAB: 2.3, MEAN: 1.7, CONFIDENCE LIMITS: 1.2-2.3. 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. FOR THE 2ND DATA SET, THE INRATIO VALUE IS BELOW THE CONFIDENCE LIMIT, BUT THE LAB VALUE IS. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS REQUIRED AT THIS TIME. BELOW ARE TESTING RESULTS. RETURNED METER AND RETURNED STRIPS LOT 070027 WERE TESTED USING THERAPEUTIC BLOOD FROM TWO DONORS. THE ACCEPTANCE CRITERIA IS AS FOLLOWS: IF THE SYSMEX INR IS LESS THAN 2.0, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE SYSMEX INR SHALL BE +/- 0.5. IF THE SYSMEX INR IS 2.0-4.5, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE SYSMEX INR SHALL BE +/- 1.0. THE TEST RESULTS OF RETURNED STRIPS LOTS 070027 DONE IN 2007, ARE AS FOLLOWS: PATIENT 1: LOT 070027: 3.0, 3.1, 3.1; SYSMEX INR: 2.8, 2.8, 2.8; DIFFERENCE: -0.2, -0.3, -0.3; RESULT: PASS, PASS, PASS. PATIENT 2: LOT 070027: 2.5, 2.4, 2.6; SYSMEX INR: 2.3, 2.3, 2.3; DIFFERENCE: -0.2, -0.1, -0.3; RESULT: PASS, PASS, PASS. BASED ON THE ABOVE TEST RESULTS, RETURNED LOT 070027 MEETS THE CRITERIA FOR STRIP ACCURACY.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 2007, INRATIO: 2.1, LAB: 1.6. DATE: 2007, INRATIO: 1.1, LAB: 2.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070027

    Patients

    Seq Age Sex Outcome Treatment
    1 YR