BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1699031 · Received May 18, 2010

    Report

    Report Number
    2027969-2010-00596
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 18, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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: (B)(6)2010; INRATIO METER=1.8 INR; REFERENCE= 2.5 INR; MEAN= 2.15; CONFIDENCE LIMITS= 1.4-3.1. TESTS ARE PERFORMED SIMULTANEOUSLY BETWEEN TWO READINGS. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED. DATA ANALYSIS REVEALED INR'S REPORTED BY END USER HAS MET ACCURACY CRITERIA. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. AS OF 05/13/2010, 26 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #225323, YIELDING A COMPLAINT RATE OF 0.015%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) NO FURTHER ACTION IS REQUIRED AT THIS TIME. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS BETWEEN COMPARISON METER RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6)2010, (B)(6)2010; TEST 1: 2.4, 1.8; TEST 2: 2.5, 2.X.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 225323

    Patients

    Seq Age Sex Outcome Treatment
    1