BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1112007 · Received August 12, 2008

    Report

    Report Number
    2954730-2008-00495
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 11, 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

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT THE TIME THE COMPLAINT WAS FILED: DATE 2008, LAB 4.8, MEAN 5.7, 5.25, CONFIDENT LIMITS: CONFIDENCE. LEVEL CANNOT BE DETERMINED SINCE MEAN IS HIGHER THAN 5. DATE 2008, INRATIO 4.8, LAB 7.7, MEAN 6.25, CONFIDENCE LIMITS: CONFIDENCE. LEVEL CANNOT BE DETERMINED SINCE MEAN IS HIGHER THAN 5. AS PER OUR INTERNAL PROCEDURE, REV, 2, THE CONFIDENCE LEVEL CANNOT BE DETERMINED SINCE THE MEAN IS GREATER THAN 5. THE PRODUCT WILL BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008; INRATIO: 4.8, LAB: 5.7, 7.7.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI