BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2040053 · Received March 9, 2011

    Report

    Report Number
    2027969-2011-00462
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 4.1, REFERENCE: 3.1, MEAN: 3.60, CONFIDENCE LIMITS: 2.0-5.0. INRATIO: 4.1, REFERENCE: 2.7, MEAN: 3.40, CONFIDENCE LIMITS: 2.0-5.0. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT BOTH INRATIO AND REFERENCE TEST RESULT COMPARISONS MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION REQUIRED. PER GENERAL DESCRIPTION OF COMPLAINT, PT WAS ON AMIODARONE AT TIME OF TESTING. PER PRODUCT USER GUIDE, CERTAIN OVER-THE-COUNTER DRUGS AND PRESCRIPTION MEDICATION CAN ALTER COAGULATION AND LEAD TO INACCURATE INRATIO RESULTS. (B)(4). ACTION THRESHOLD WAS REACHED. SINCE RELEASE OF STRIP LOT, IN-HOUSE THERAPEUTIC SAMPLE TESTS WERE PERFORMED ON RETAIN AND RETURNED STRIPS. CUSTOMER'S OBSERVATIONS HAVE NOT BEEN REPRODUCED IN TESTS. TEST RECORDS INDICATED THAT 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 AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER (NURSE FOR PT) ALLEGED DISCREPANT RESULTS COMPARED WITH ANOTHER SYSTEM AND THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 4.1, COAGUCHEK: 3.1, LAB: 2.7. PT HAD A SALAD ON THE NIGHT OF (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI