BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 771594 · Received August 11, 2006

    Report

    Report Number
    2954730-2006-00444
    Event Type
    Malfunction
    Date Received
    August 11, 2006
    Date of Event
    August 2, 2006
    Report Date
    August 3, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE 08/02/2006, INRATIO 4.3, LAB 3.4, MEAN 3.85, CONFIDENCE LIMITS 2.3-5.7; DATE 08/02/2006, INRATIO 4.0, LAB 3.3, MEAN 3.65, CONFIDENCE LIMITS 2.2-5.3. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE 08/02/2006, INRATIO 4.3, LAB 3.4; DATE 08/02/2006, INRATIO 4.0, LAB 3.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060102

    Patients

    Seq Age Sex Outcome Treatment
    1 *