BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 793562 · Received December 1, 2006

    Report

    Report Number
    2954730-2006-00591
    Event Type
    Malfunction
    Date Received
    December 1, 2006
    Date of Event
    November 17, 2006
    Report Date
    November 29, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060415: FIRST TEST INR = 1.0; SECOND TEST INR = 2.1; MEAN = 1.55; SD = 0.77; %CV = 50%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 1.0; SECOND TEST INR = 2.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060415

    Patients

    Seq Age Sex Outcome Treatment
    1 *