BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2351198 · Received October 17, 2011

    Report

    Report Number
    2027969-2011-02148
    Event Type
    Malfunction
    Date Received
    October 17, 2011
    Date of Event
    September 22, 2011
    Report Date
    October 17, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA ANALYSIS WAS PERFORMED BECAUSE >7.5 IS NOT A REAL NUMBER. THE INRATIO >7.5 AND COMPARATIVE SYSTEM LESS THAN 5.0. THESE RESULTS ARE CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. ADD'L INVESTIGATION IS REQUIRED. PER GENERAL DESCRIPTION, CUSTOMER PRODUCED GREATER THAN 7.5 INR. INRATIO METER MEASURES INR RANGE FROM 0.7-7.5 INR. THIS UNEXPECTED RESULTS ARE CAUSED BY OF THE FOLLOWING: A HEMATOCRIT THAT IS HIGHER OR LOWER THAN THE VALIDATED OPERATING RANGE OF THE INRATIO SYSTEM CAN CAUSE INACCURATE RESULT. LUPUS OR ANTIPHOSPHOLIPID ANTIBODY SYNDROME (APS) MAY FALSELY PROLONG THE INR VALUE. CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS THAT CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS AND THE INR VALUE. LIVER DISEASE, CONGESTIVE HEART FAILURE, THYROID DYSFUNCTION, AND OTHER DISEASES OR CONDITIONS CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS AND THE INR VALUE. CHANGES IN DIET, LIFESTYLE, OR TAKING NUTRITIONAL SUPPLEMENTS SUCH AS GINKGO BILOBA CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS AND THE INR VALUE. RECENT TEST CONDUCTED ON LOT 253026 ON 9/14/2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 102 = 2.0, 1.8, 1.9 INR; DONOR 103 = 2.6, 2.6, 2.7 INR. AT LEAST TWO OUT OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (CHANGE TO + OR - 1.0) OF REFERENCE RESULTS FOR DONOR 102 (1.75 INR) AND DONOR 103 (2.56 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (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. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: >7.5, LAB: 1.98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 253026

    Patients

    Seq Age Sex Outcome Treatment
    1