BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2987891 · Received April 30, 2007

    Report

    Report Number
    2954730-2007-00213
    Event Type
    Malfunction
    Date Received
    April 30, 2007
    Date of Event
    April 17, 2007
    Report Date
    April 26, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    GJS
    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 = 1.4, SECOND TEST INR = 2.3, MEAN = 1.85; SD = 0.63; %CV = 35%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060819: FIRST TEST INR = 3.8 (FIRST UNIT), SECOND TEST INR = 4.5 (SECOND UNIT), MEAN = 4.15; SD = 0.49; %CV = 12%. 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 METER. RESULTS AS FOLLOWS: FIRST TEST INR = 1.4, SECOND TEST INR = 2.3. FIRST TEST INR = 2.3. FIRST TEST INR = 3.8 (FIRST UNIT), SECOND TEST INR = 4.5 (SECOND UNIT).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1