BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 896705 · Received July 13, 2007

    Report

    Report Number
    2954730-2007-00357
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    July 19, 2007
    Report Date
    July 31, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070274: FIRST TEST INR = 2.5, SECOND TEST INR = 1.6, MEAN = 2.05; SD = 0.64; %CV = 31.0%. FIRST TEST INR = 4.0, SECOND TEST INR = 4.2, THIRD TEST INR = 2.8, FOURTH TEST INR = 3.9, MEAN = 3.73; SD = 0.76; %CV = 20.3%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILS THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 2.5, SECOND TEST INR = 1.6, FIRST TEST INR = 4.0, SECOND TEST INR = 4.2; THIRD TEST INR = 2.8, FOURTH TEST INR = 3.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070274

    Patients

    Seq Age Sex Outcome Treatment
    1 YR