BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 731975 · Received June 23, 2006

    Report

    Report Number
    2954730-2006-00369
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    June 16, 2006
    Report Date
    June 21, 2006
    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 060102 06/16/06 FIRST TEST INR = 4.3, SECOND TEST INR =5.0, THIRD TEST INR = 5.2. MEAN =4.83; SD =0.47; %CV = 9.77%. 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 IMPRECISON RESULTS WITH INRATIO. RESULTS AS FOLLOWS: 06/16/06 FIRST TEST INR = 4.3 SECOND TEST INR = 5.0 THIRD TEST INR = 5.2

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *