BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 862194 · Received June 4, 2007

    Report

    Report Number
    2954730-2007-00241
    Event Type
    Malfunction
    Date Received
    June 4, 2007
    Date of Event
    May 10, 2007
    Report Date
    May 22, 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 #070131; FIRST TEST INR = 5.0, SECOND TEST INR = 4.3, MEAN = 4.65; SD = 0.49; %CV = 10.6%. FIRST TEST INR = 3.2, SECOND TEST INR = 2.4, MEAN = 2.80; SD = 0.57; %CV = 20.2%. FIRST TEST INR = 3.6, SECOND TEST INR = 4.0, THIRD TEST INR 4.0, MEAN = 3.9; SD = 0.23; %CV = 6.0. THE %CV IS GREATER THAN 20% FOR THE SECOND SET OF DATA. THE %CV FOR THE FIRST AND SECOND SET OF DATA IS LESS THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILS CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 5.0, SECOND TEST INR = 4.3; FIRST TEST INR = 3.2, SECOND TEST INR = 2.4; FIRST TEST INR = 3.6, SECOND TEST INR = 4.0, THIRD TEST INR 4.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070131

    Patients

    Seq Age Sex Outcome Treatment
    1 YR