BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2243857 · Received July 29, 2011

    Report

    Report Number
    2027969-2011-01683
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER GENERAL DESCRIPTION, CUSTOMER PRODUCED GREATER THAN 7.5 INR. INRATIO METER MEASURES INR RANGE FROM 0.7-7.5 INR. THESE UNEXPECTED RESULTS MAY BE CAUSED BY 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 GINKO BILOBA CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS AND THE INR VALUE. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED. DATE: (B)(6) 2011, INRATIO: >7.5, REFERENCE: 2.1. 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. ADDITIONAL INVESTIGATION IS REQUIRED. RECENT TEST CONDUCTED ON LOT 253026 ON 07/13/2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 72 = 4.3, 4.2, 4.4 INR; DONOR 73 = 2.6, 2.1, 2.5 INR. AT LEAST TWO OUT OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+/- 1.0) OF REFERENCE RESULTS FOR DONOR 72 (3.93 INR) AND DONOR 73 (2.30 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CONCLUSION: CUSTOMER WAS UNSURE WHAT TYPE OF CAP TUBES ARE BEING USED FOR INRATIO TESTING. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET ACCURACY CRITERIA. (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 INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: >7.5, LAB: 2.1. TESTS WERE DONE WITHIN 30 MINUTES OF EACH OTHER. CALLER WAS NOT TEST OPERATOR AND SO WAS UNABLE TO VERIFY PROCEDURE THAT WAS USED FOR TESTING. CALLER WAS UNSURE WHICH CAP TUBE WAS USED AS THEY HAVE SEVERAL DIFFERENT TYPES.

    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