BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2982228 · Received June 9, 2006

    Report

    Report Number
    2954730-2006-00348
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Date of Event
    June 7, 2006
    Report Date
    June 8, 2006
    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 060019: (B)(6) 2006 FIRST TEST INR = 31.2 SECOND TEST INR = 2.8 THIRD TEST INR = 2.0. MEAN = 2.0; SD =08; %CV = 40%. THE % CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCT WILL BE INVESTIGATED.

    Description of Event or Problem · 1

    CALLER ALLEGED POOR PRECISION WITH THE RESULTS. RESULTS AS FOLLOWS: (B)(6) 2006 FIRST TEST INR = 31.2. SECOND TEST INR = 2.8. THIRD TEST INR = 2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS HEMOSENSE, INC. 0060019

    Patients

    Seq Age Sex Outcome Treatment
    1