BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 962214 · Received April 26, 2007

    Report

    Report Number
    2954730-2007-00206
    Event Type
    Other
    Date Received
    April 26, 2007
    Date of Event
    April 18, 2007
    Report Date
    April 23, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Adverse Event
    Yes
    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: 2007; INRATIO: 2.2; LAB:3.78; MEAN: 2.99; CONFIDENCE LIMITS: 1.8-4.2. PER INTERNAL PROCEDURE, TR 0150, 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. THIS CASE QUALIFIES AS AN ADVERSE EVENT BECAUSE DUE TO THE MEDICATION DOSAGE CHANGES. AN RGA WILL BE CREATED TO REQUEST BOTH METER AND TEST STRIPS TO BE RETURNED FOR INVESTIGATION. TS UPDATED ON 04/23/2007. FOLLOW UP REVEALS THAT THE INR WITH NEW STRIPS CAME BACK AT 3.3 WITHIN HIS RANGE. HE IS HAPPY WITH THE PRODUCT PERFORMANCE AND HAS NO FURTHER ISSUES OR QUESTIONS.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS ARE AS FOLLOWS. DATE: 2007; INRATIO: 2.2; LAB: 3.78. DOSE ADJUSTMENT OCCURRED SO THIS QUALIFIES AS AN ADVERSE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *