BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 905416 · Received August 27, 2007

    Report

    Report Number
    2954730-2007-00395
    Event Type
    Malfunction
    Date Received
    August 27, 2007
    Date of Event
    August 7, 2007
    Report Date
    August 22, 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, INRATIO: >7.5, LAB: 5.3, MEAN: UNABLE TO BE DETERMINED, CONFIDENCE LIMIT: UNABLE TO BE DETERMINED. DATE: NINE DAYS LATER, INRATIO: 5.1, LAB: 3.1, MEAN: 4.1, CONFIDENCE LIMITS: 2.4-6.1. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE 1ST DATA SET, THE MEAN CONFIDENCE LIMITS CANNOT BE CALCULATED BECAUSE THE INRATIO VALUE IS >7.5. FOR THE 2ND DATA SET, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. 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 070163: FIRST TEST INR=>7.5, SECOND TEST INR= >7.5, MEAN = UNABLE TO BE DETERMINED; SD = UNABLE TO BE DETERMINED; %CV = UNABLE TO BE DETERMINED. THE %CV CANNOT BE DETERMINED. BOTH RESULTS WERE GREATER THAN 7.5. PER INTERNAL PROCEDURE, THE PRECISION FAILS THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 2007, INRATIO: >7.5 LAB: 5.3. DATE: NINE DAYS LATER, INRATIO: 5.1 LAB: 3.1. CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = >7.5 SECOND TEST INR= >7.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070163

    Patients

    Seq Age Sex Outcome Treatment
    1 YR