BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1070792 · Received July 3, 2008

    Report

    Report Number
    2954730-2008-00448
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 2, 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 070781: FIRST TEST INR = 7.3; SECOND TEST INR = 5.3; THIRD TEST INR = 6.1; MEAN = 6.23; SD = 1.0; %CV = 16%. THE % CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, 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 = 7.3, SECOND TEST INR = 5.3, THIRD TEST INR = 6.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100004 070781

    Patients

    Seq Age Sex Outcome Treatment
    1 NI