BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2000021 · Received February 17, 2011

    Report

    Report Number
    2027969-2011-00359
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    February 4, 2010
    Report Date
    February 17, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    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: 2.5, REFERENCE: 3.0, MEAN: 2.75, CONFIDENCE LIMITS: 1.7 - 3.8. DATE: (B)(6) 2010, INRATIO: 2.9, REFERENCE: 3.5, MEAN: 3.20, CONFIDENCE LIMITS: 1.9 - 4.6. DATE: UNKNOWN, INRATIO: 3.5, REFERENCE: 3.8, MEAN: 3.65, CONFIDENCE LIMITS: 2.2 - 5.3. 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 RESULTS FROM (B)(6) 2011 AND (B)(6) 2011 WERE EXCLUDED FROM DATA ANALYSIS BECAUSE TIME BETWEEN TESTS EXCEEDED THREE HOURS. SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4) NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 2.5, LAB: 3.0. DATE: (B)(6) 2010, INRATIO: 2.9, LAB: 3.5. DATE: UNKNOWN, INRATIO: 3.5, LAB: 3.8. DATE: (B)(6) 2011, INRATIO: 3.0. DATE: (B)(6) 2011, LAB: 4.0. PATIENT WAS DUE FOR AN ANGIOPLASTY ON (B)(6) 2011 AND SO COUMADIN WAS STOPPED ON (B)(6) 2011. FOLLOWING LAB INR RESULTS ON (B)(6) 2011, ANGIOPLASTY PROCEDURE WAS CANCELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243699

    Patients

    Seq Age Sex Outcome Treatment
    1