BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1060377 · Received June 11, 2008

    Report

    Report Number
    2954730-2008-00189
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    March 13, 2008
    Report Date
    June 10, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 2008; INRATIO 4.5; LAB 7.2; MEAN 5.9; CONFIDENCE LIMITS: UNABLE TO BE DETERMINED. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS INR WERE CALCULATED. THE READINGS ARE CONSIDERED INACCURATE BASED ON "AREA OUTSIDE THE ACCEPTANCE REGION" TABLE. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 2008; INRATIO: 4.5; LAB 7.2. THIS CASE QUALIFIES AS AN ADVERSE EVENT. PT WAS GIVEN VITAMIN K FOR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. KIT, PROFESSIONAL USER, ENGLISH 0707384

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention