BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 856266 · Received May 25, 2007

    Report

    Report Number
    2954730-2007-00245
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Date of Event
    May 23, 2007
    Report Date
    May 25, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060541: FIRST TEST INR = 6.7, SECOND TEST INR = 5.2; MEAN = 5.95; SD = 1.06; %CV = 17.8%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2007, INRATIO: 6.7, 5.2; LAB: 3.5, 3.5; MEAN: 5.1, 4.35; CONFIDENCE LIMITS CANNOT BE DETERMINED 2.5-6.5. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST SET OF DATA, THE CONFIDENCE LIMITS CANNOT BE DETERMINED. PRODUCTS WILL BE TESTED WHEN RETURNED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060541: FIRST TEST INR = 4.8, SECOND TEST INR = 2.1; MEAN = 3.45; SD = 1.9; %CV = 55%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED WHEN RETURNED. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2007, INRATIO: 4.8, 2.1, 2.8, 1.7; LAB: 3.5, 3.5, 2.1, 1.5; MEAN: 4.15, 2.8, 2.45, 1.6; MEAN: 4.15, 2.8, 2.45, 1.6; CONFIDENCE LIMITS 2.4-6.1, 1.8-4.2, 1.6-3.4, 1.2-2.3. 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.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: FIRST TEST INR = 6.7, SECOND TEST INR = 5.2. CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2007, INRATIO: 6.7, 5.2; LAB: 3.5, 3.5. UPDATED THIS CASE IN 2007. FIRST TEST INR = 4.8, SECOND TEST INR = 2.1. DATE: 2007 INRATIO: 4.8, 2.1, 2.8, 1.7; LAB: 3.5, 3.5, 2.1, 1.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 060541

    Patients

    Seq Age Sex Outcome Treatment
    1 YR