BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 810140 · Received January 9, 2007

    Report

    Report Number
    2954730-2007-00010
    Event Type
    Malfunction
    Date Received
    January 9, 2007
    Date of Event
    December 18, 2006
    Report Date
    January 9, 2007
    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 060452: FIRST TEST INR = 3.7, SECOND TEST INR = 5.3, MEAN = 4.5; SD = 1.13; %CV = 25.1%. THE %CV IS GREATER THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME. INRATIO PRECISION DATA PROVIDED BE END-USER LOT 060452: FIRST TEST INR = 3.7, THIRD TEST INR = 4.4, MEAN = 4.05; SD = 0.49; %CV = 12.2%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 3.7, SECOND TEST INR = 5.3. FIRST TEST INR = 3.7, THIRD TEST INR = 4.4. CALLER ALLEGED INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 12/18/2006, INRATIO: 5.80, LAB: 4.64, MEAN: 5.22, CONFIDENCE LIMITS: UNABLE TO BE DETERMINED. DATE: 12/18/2006, INRATIO 3.70, LAB: 4.40, MEAN: 3.90, CONFIDENCE LIMITS: 2.3 - 5.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GIS HEMOSENSE, INC. * 060452

    Patients

    Seq Age Sex Outcome Treatment
    1 *