BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 893006 · Received August 10, 2007

    Report

    Report Number
    2954730-2007-00365
    Event Type
    Malfunction
    Date Received
    August 10, 2007
    Date of Event
    July 24, 2007
    Report Date
    August 7, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: SEE SCANNED TABLE. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR ONE SET OF DATA (INRATIO = 3.3, SAH = 1.5) THE LAB VALUE WAS OUTSIDE THE CONFIDENCE LIMITS FOR INR TESTING. PRODUCTS WILL BE TESTED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: SEE SCANNED TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070132

    Patients

    Seq Age Sex Outcome Treatment
    1 YR