BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 887471 · Received July 27, 2007

    Report

    Report Number
    2954730-2007-00347
    Event Type
    Malfunction
    Date Received
    July 27, 2007
    Date of Event
    July 19, 2007
    Report Date
    July 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 070163: FIRST TEST INR = 1.2, SECOND TEST INR = 1.3, MEAN = 1.25; SD = 0.07, %CV = 5.66%. 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: PT 1: DATE 2007, INRATIO: 1.2, LAB 3.2, MEAN 2.2, CONFIDENCE LIMITS: 1.4 - 3.1, DATE: THE SAME DAY, INRATIO 1.3, LAB 3.2, MEAN: 2.25, CONFIDENCE LIMITS: 1.4 - 3.1. PT 2: DATE THE SAME DAY, INRATIO 1.3, LAB 2.6, MEAN 1.95, CONFIDENCE LIMITS: 1.3 - 2.7. THE NEXT DAY, INRATIO 1.9, LAB 1.98, MEAN 1.94, CONFIDENCE LIMITS: 1.3 - 2.7. 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 FOR PT 2 DATED THE ORIGINAL DATE AND THE READING FOR THE FOLLOWING DAY. FOR PT 1, BOTH INRATIO AND LAB VALUES ARE 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 = 1.2, SECOND TEST INR = 1.3. CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: PATIENT 1: DATE 2007, INRATIO 1.2, LAB 3.2, DATE: THE SAME DAY, INRATIO 1.3, LAB 3.2. PT 2: DATE: THE SAME DAY, INRATIO 1.3, LAB 2.6, THE FOLLOWING DAY, INRATIO 1.9, LAB 1.98.

    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