BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1067304 · Received June 27, 2008

    Report

    Report Number
    2954730-2008-00440
    Event Type
    Malfunction
    Date Received
    June 27, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 26, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070615: PT#1 FIRST TEST INR = 4.0, SECOND TEST INR = 1.7, THIRD TEST INR = 2.4; MEAN = 2.7; SD = 1.2; %CV = 43%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070615: PT#2 FIRST TEST INR = 2.5, SECOND TEST INR = 3.2, THIRD TEST INR = 4.3; MEAN = 3.3; SD = 0.9; %CV = 27%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070615: PT#3 FIRST TEST INR = 1.7, SECOND TEST INR = 2.4; MEAN = 2.05; SD = 0.49; %CV = 24%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070615: PT# 4 FIRST TEST INR = 6.4, SECOND TEST INR = 7.0; MEAN = 6.7; SD = 0.42; %CV = 6.3%. 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 IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: PT#1 FIRST TEST INR = 4.0, SECOND TEST INR = 1.7, THIRD TEST INR = 2.4. PT#2 FIRST TEST INR = 2.5, SECOND TEST INR = 3.2, THIRD TEST INR = 4.3. PT#3 FIRST TEST INR = 1.7, SECOND TEST INR = 2.4. PT#4 FIRST TEST INR = 6.4, SECOND TEST INR = 7.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100004 070615

    Patients

    Seq Age Sex Outcome Treatment
    1 NI