BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 864874 · Received June 8, 2007

    Report

    Report Number
    2954730-2007-00265
    Event Type
    Malfunction
    Date Received
    June 8, 2007
    Date of Event
    May 15, 2007
    Report Date
    June 8, 2007
    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: 2007, INTRATIO 4.6 (PT#1), LAB 3.3, MEAN 3.95 CONFIDENCE LIMITS 2.3-5.7. DATE: THE SAME DAY, INTRATIO 4.7 (PT#2), LAB 3.6, MEAN 4.15, CONFIDENCE LIMITS 2.4-6.1. DATE: THE NEXT DAY, INTRATIO 2.4 (PT#1), LAB 2.3, MEAN 2.35, CONFIDENCE LIMITS 1.6-3.4. 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. TS UPDATED THIS CASE IN 2007. DATE: THE SAME DAY, INTRATIO 2.0 (PT#1), LAB 1.9, MEAN 1.95, CONFIDENCE LIMITS 1.3-2.7. DATE: THE SAME DAY, INTRATIO 3.0 (PT#2), LAB 2.5, MEAN 2.75, CONFIDENCE LIMITS 1.7-3.8. DATE: THE SAME DAY, INTRATIO 3.0 (PT#3), LAB 2.7, MEAN 2.85, CONFIDENCE LIMITS 1.8-4.2. DATE: THE SAME DAY, INTRATIO 2.4 (PT#4), LAB 2.3, MEAN 2.35, CONFIDENCE LIMITS 1.6-3.4. 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 FURT.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE 05/14/07, INTRATIO 4.6 (PT#1), LAB 3.3, DATE 2007, INTRATIO 4.7 (PT#2), LAB 3.6, DATE: THE NEXT DAY, INTRATIO 2.4 (PT#1), LAB 2.3, DATE: ONE DAY LATER, INTRATIO 2.0 (PT#1), LAB 1.9, DATE: THE SAME DAY, INTRATIO 3.0 (PT#2), LAB 2.5, DATE: THE SAME DAY, INTRATIO 3.0 (PT#3), LAB 2.7, DATE: THE SAME DAY, INTRATIO 2.4 (PT#4), LAB 2.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070070

    Patients

    Seq Age Sex Outcome Treatment
    1 YR