BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2130354 · Received May 9, 2011

    Report

    Report Number
    2027969-2011-01021
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 8, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST RESULT(S) WITH LAB RESULT(S) PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 1.5, LAB: 2.3, MEAN: 1.9, CONFIDENCE LIMITS: 1.3 - 2.7, RESULT: PASS. REPORTED RESULTS ARE WITHIN THE CONFIDENCE LIMITS FOR PASSING ACCURACY COMPARISON. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. USER REPORTED PATIENT THYROID CONDITION. PER PRODUCT INSERT, "LIVER DISEASE, CONGESTIVE HEART FAILURE, THYROID DYSFUNCTION AND OTHER DISEASES OR CONDITIONS CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS AND THE INR VALUE." USER ALSO REPORTED PERFORMING FINGER-STICK PRIOR TO SAMPLE INDICATOR ACTIVATION. EITHER OR BOTH OF THESE ISSUES COULD HAVE BEEN A CONTRIBUTING CAUSE TO THE RESULT DISPARITY. IN-HOUSE RETAIN TESTING HAS BEEN PERFORMED ON REPORTED LOT #241836 ON (B)(6) 2011. RESULTS AS FOLLOWS: INRATIO: 2.4, INRATIO: 2.7, INRATIO: 2.8, REFERENCE: 2.82, BIAS THRESHOLD: 1.82 - 3.82. INRATIO: 2.9, INRATIO: 3.0, INRATIO: 2.7, REFERENCE: 2.56, BIAS THRESHOLD: 1.56 - 3.56. (B)(4). ACTION THRESHOLD (B)(4) HAS REACHED. SINCE STRIP LOT RELEASED, 6 IN-HOUSE THERAPEUTIC SAMPLE TESTS WERE PERFORMED FOR RETAIN AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE TEST. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.5, LAB: 2.3. PATIENT'S THERAPEUTIC RANGE: 2-3. PATIENT IS PRICKING FINGER PRIOR TO TURNING METER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1 NI