BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 866179 · Received June 15, 2007

    Report

    Report Number
    2954730-2007-00274
    Event Type
    Malfunction
    Date Received
    June 15, 2007
    Date of Event
    May 23, 2007
    Report Date
    June 15, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060819: FIRST TEST INR = 7.4 SECOND TEST INR = 6.3. MEAN = 6.85; SD = 0.77; %CV = 11%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, 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 2007, INRATIO 7.4, 6.3; LAB 4.2, 4.2; MEAN 5.8, 5.25; CONFIDENCE LIMITS: CANNOT BE DETERMINED. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST SET OF DATA, THE MEAN WAS > 5.0 AND THE DIFFERENCE BETWEEN INR'S > 2.2. THE VALUES WAS CONSIDERED INACCURATE. PRODUCTS WILL BE TESTED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060819: FIRST TEST INR = 1.0 SECOND TEST INR = 1.6 MEAN = 1.3; SD = 0.42; %CV = 32%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE 2007, INRATIO: 7.4, 6.3; LAB 4.2, 4.2. CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOW; FIRST TEST INR =1.0, 7.4; SECOND TEST INR = 1.6, 6.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 060819

    Patients

    Seq Age Sex Outcome Treatment
    1 YR