BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 885401 · Received September 8, 2006

    Report

    Report Number
    2954730-2006-00489
    Event Type
    Malfunction
    Date Received
    September 8, 2006
    Date of Event
    September 1, 2006
    Report Date
    September 5, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    GIS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060102: IN 2006: FIRST TEST INR = 4.3; SECOND TEST INR = 4.;1 MEAN = 4.2; SD= 0.14, % CV = 3.3%. THE %CV IS LESS THAN OUR EQUAL TO 20%. PER INTERNAL PROCEDURE, TR, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE:2006; INRATIO:3.1(2PM); LAB:4.3(9:30PM); MEAN:3.7; CONFIDENCE LIMITS:2.2-5.3; INRATIO:3.1(2PM); LAB:4.1(9:30PM); MEAN:3.6; CONFIDENCE LIMITS:2.2-5.3. PER INTERNAL PROCEDURE, TR, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS NOT REQUIRED AT THIS TIME. THE TIME INTERVAL BETWEEN INRATIO AND LAB WAS > 3 HOURS. PER TR, THE COMPARISON CONSIDERED INVALID.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: IN 2006; INRATIO:3.1(2PM); LAB:4.3(9:30PM); INRATIO:3.1(2PM); LAB:4.1(9:30PM). CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: IN 2006; FIRST TEST INR = 4.3; SECOND TEST INR = 4.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GIS HEMOSENSE, INC. * 060102

    Patients

    Seq Age Sex Outcome Treatment
    1 *