BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 923876 · Received October 4, 2007

    Report

    Report Number
    2954730-2007-00465
    Event Type
    Malfunction
    Date Received
    October 4, 2007
    Date of Event
    September 10, 2007
    Report Date
    October 1, 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: 070382. FIRST TEST INR = 2.9, SECOND TEST INR = 1.1, THIRD TEST INR = 2.9. MEAN = 2.2; SD = 0.96; %CV = 43.8%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILS THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND 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 2.9, LAB 1.0, MEAN 2.0, CONFIDENCE LIMITS 1.3 - 2.7. DATE 2007, INRATIO 1.1, LAB 1.0, MEAN 1.1, CONFIDENCE LIMITS 1.0 - 1.5. DATE 2007 INRATIO 2.6, LAB 1.0, MEAN 1.8, CONFIDENCE LIMITS 1.3 - 2.7. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE 2ND DATA SET, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. FOR THE 1ST AND 3RD DATA SET, THE LAB VALUE IS NOT WITHIN THE CONFIDENCE LIMITS. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR=2.9; SECOND TEST INR = 1.1; THIRD TEST INR = 2.9. CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE 2007 INRATIO 2.9, LAB 1.0. DATE 2007 INRATIO 1.1, LAB 1.0. DATE 2007 2.6, LAB 1.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070382

    Patients

    Seq Age Sex Outcome Treatment
    1 YR