BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 953835 · Received November 19, 2007

    Report

    Report Number
    2954730-2007-00577
    Event Type
    Malfunction
    Date Received
    November 19, 2007
    Date of Event
    October 31, 2007
    Report Date
    November 19, 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: PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE 1ST DATA SET, BOTH INRATIO AND LAB VALUES ARE NOT WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. FOR THE 2ND, 3RD, 4TH, AND 6TH DATA SET, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS. FOR THE 5TH DATA SET, THE INRATIO VALUE IS NOT WITH THE CONFIDENCE LIMITS BUT THE LAB VALUE IS. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS REQUIRED AT THIS TIME. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: 070381. FIRST TEST INR = 1.2 SECOND TEST INR = 1.4 MEAN = 1.3; SD = 0.14; %CV = 10.9%. FIRST TEST INR = 2.7 SECOND TEST INR = 2.9 MEAN = 2.8; SD = 0.14; %CV = 5.05%. THE %CV IS LESS THAN 20% FOR BOTH DATA SET. PER INTERNAL PROCEDURE, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: IN 2007, INRATIO: 1.2 (070180), LAB: 3.5. DATE: FOUR DAYS LATER, INRATIO: 2.7 (070180), LAB: 4.2. DATE: THE NEXT DAY, INRATIO: 1.2 (070381), LAB: 1.39. DATE: THE SAME DAY, INRATIO: 1.4 (070381), LAB: 1.39. DATE: ONE DAY LATER, INRATIO: 2.7 (070381), LAB: 7.1. DATE: THE SAME DAY, INRATIO: 2.9 (070381), LAB: 7.1. CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 1.2 SECOND TEST INR = 1.4. FIRST TEST INR = 2.7 SECOND TEST INR = 2.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070180

    Patients

    Seq Age Sex Outcome Treatment
    1 YR