BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 771584 · Received August 11, 2006

    Report

    Report Number
    2954730-2006-00446
    Event Type
    Malfunction
    Date Received
    August 11, 2006
    Date of Event
    August 9, 2006
    Report Date
    August 10, 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 060128: 08/09/2006 FIRST TEST INR = 0.9, SECOND TEST INR = 2.2, MEAN = 1.55; SD = 0.92; %CV = 59%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE INVESTIGATED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION RESULTS WITH INRATIO. RESULTS AS FOLLOWS: 08/09/2006 FIRST TEST INR = 0.9, SECOND TEST INR = 2.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060128

    Patients

    Seq Age Sex Outcome Treatment
    1 *