BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1064147 · Received June 20, 2008

    Report

    Report Number
    2954730-2008-00430
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 19, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070454: FIRST TEST INR = 1.4; SECOND TEST INR = 2.5 MEAN = 1.95 ; SD = 0.77; %CV = 40%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 01510, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS ARE AS FOLLOWS: FIRST TEST INR = 1.4; SECOND TEST INR = 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100071 070454A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI