BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 938525 · Received November 5, 2007

    Report

    Report Number
    2954730-2007-00537
    Event Type
    Malfunction
    Date Received
    November 5, 2007
    Date of Event
    October 10, 2007
    Report Date
    October 23, 2007
    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 OF COMPLAINT WAS FILED. SEE SCANNED TABLE. PER INTERNAL PROCEDURE, TR 0150, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR DATA SET 1, THE STRIP LOT NUMBER USED IS UNKNOWN AND WAS ALL USED UP. PATIENT WAS ALSO GIVEN VITAMIN K. FOR DATA SETS 2-11, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. STRIP LOT USED FOR DATA SETS 2-11 WAS 070325. NO INTERVENTION WAS PERFORMED, ONLY HELD COUMADIN DOSE FOR PATIENT IN DATA SET #5. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS REQUIRED AT THIS TIME. THIS CASE QUALIFIES AS AN ADVERSE EVENT, VITAMIN K WAS GIVEN. ADVERSE EVENT FOLLOW UP: PATIENT IS NOW STABLE AND IS DOING FINE.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070325

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention