BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1686428 · Received May 10, 2010

    Report

    Report Number
    2027969-2010-00562
    Event Type
    Malfunction
    Date Received
    May 10, 2010
    Date of Event
    November 2, 2009
    Report Date
    May 10, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: NONE, INRATIO: 3.6 INR, REF: 1.9 INR, MEAN: 2.75, CONFIDENCE LIMITS: 1.7-3.8. NONE, 4.3 INR , 1.9 INR, 2.5, 1.8-4.2. THREE HOURS IN CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES OF TEST 2 FALLS OUTSIDE THE LIMITS, SO THE CRITERIA IS NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. STRIP L/N: 80731A HAS EXPIRED ON THE LAST DAY OF (B)(6) 2009. PREVIOUS INVESTIGATION ON STRIP L/N: 80731A FROM EVENT (B)(4) (NETRM) HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED. INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: NONE, 1ST INR = 3.6, 2ND INR = 4.3, MEAN = 3.95, SD = 0.49, %CV = 12.53, SINCE 12.53 % CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED. CUSTOMER USING EXPIRED STRIPS CAUSED INCORRECT READING. DEVICE WAS USED IN WAYS NOT ANTICIPATED BY THE MANUFACTURER. DUE TO THE LOW OCCURRENCE OF THE ISSUE, THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION OR VIGILANCE REPORT IS REQUIRED AT THIS TIME. CUSTOMER ALSO USED INRATIO2 DEVICE 510 (K) 072727. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS BETWEEN INRATIO METERS. RESULTS AS FOLLOWS: DATE: (B)(6)2009, METER 1: 6.1, METER 2: 4.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 080731A

    Patients

    Seq Age Sex Outcome Treatment
    1