BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 817670 · Received January 31, 2007

    Report

    Report Number
    2954730-2007-00059
    Event Type
    Malfunction
    Date Received
    January 31, 2007
    Date of Event
    January 25, 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: 01/25/2007, INRATIO: 1.1, LAB: 3.4, MEAN: 2.3, CONFIDENCE LIMITS: 1.6 - 3.4. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE IN RATIO VALUE IS NOT WITHIN THE CONFIDENCE LIMITS, BUT LAB VALUE IS WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY OF INR TESTING. THEREFORE, FURTHER TESTING IS REQUIRED AT THIS TIME. IN-HOUSE RETAINS STRIPS LOT 060201 WERE TESTED USING THERAPEUTIC BLOOD FROM TWO DONORS. THE ACCEPTANCE CRITERIA IS AS FOLLOWS: IF THE MLA INR IS LESS THAN 2.0, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND MLA INR SHALL BE +/-0.5. IF THE MLA INR IS 2.0 - 4.5, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE MLA INR SHALL BE +/- 1.0. THE TEST RESULTS OF RETAINS STRIPS LOT 060201 ON 10/03/2006 ARE AS FOLLOWS: PT1: LOT 060201; 2.4, 2.4, 2.6. MLA INR: 2.1, 2.1, 2.1. DIFFERENCE: -0.3, -0.3, -0.5. RESULT: PASS, PASS, PASS. PT2: LOT 060201; 3.7, 3.5, 3.7. MLA INR: 3.3, 3.3, 3.3. DIFFERENCE: -0.4, -0.2, -0.4. RESULT: PASS, PASS, PASS. BASED ON THE ABOVE TEST RESULTS, RETAINED LOT 060201 MEETS THE CRITERIA FOR STRIP ACCURACY.

    Description of Event or Problem · 1

    CALLER ALLEGED INACCURACY WITH INRATIO: RESULTS AS FOLLOWS: INRATIO: 1.1, LAB: 3.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060201

    Patients

    Seq Age Sex Outcome Treatment
    1 *