BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1082046 · Received July 23, 2008

    Report

    Report Number
    2954730-2008-00470
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 21, 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 070650: FIRST TEST INR = 0.7; SECOND TEST INR =1.8; MEAN = 1.25; SD = 0.78; %CV = 62%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: FIRST TEST INR = 0.7; SECOND TEST INR = 1.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100004 070650

    Patients

    Seq Age Sex Outcome Treatment
    1 NI