BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2220027 · Received July 13, 2011

    Report

    Report Number
    2027969-2011-01541
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER ISSUE, PT ATE SPINACH WHICH IS HIGH IN VITAMIN K. PTS WITH VITAMIN K INTAKE CAN PROMOTE INCREASED PRODUCTION OF VITAMIN K CLOTTING FACTORS, DECREASING THE ANTICOAGULANT RESPONSE. ALTERNATELY, DECREASED CONSUMPTION CAN INCREASE THE ANTICOAGULANT RESPONSE. PT HAS HYPOTHYROIDISM AND IS TAKING A LOW DOSE TREATMENT. PT CURRENT MEDICATION AND HEALTH STATUS MAY AFFECT COAGULATION TEST. THIS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR. INR RESULT FROM (B)(6) 2011, WAS EXCLUDED FROM DATA ANALYSIS, BECAUSE TIME BETWEEN TESTS EXCEEDED THREE HOURS. SINCE TIME BETWEEN THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 5.0, REFERENCE: 3.4, MEAN: 4.2, CONFIDENCE LIMITS: 2.4 - 6.1. 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 NO CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO FURTHER INVESTIGATION IS REQUIRED. RECENT TEST CONDUCTED ON LOT 243104 ON (B)(6) 2011, MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 66 = 2.2, 2.0, 2.2 INR; DONOR 67 = 3.2, 3.2, 3.3 INR. AT LEAST TWO OUT OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 66 (1.95 INR) AND DONOR 67 (2.99 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. PT'S CONDITION MAY HAVE CONTRIBUTED TO UNEXPECTED RESULTS. CHANGE OF DIET MAY AFFECT INR TEST RESULT. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET 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. 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: 5.0. DATE: (B)(6) 2011, INRATIO: 5.0, LAB: 3.4. PT'S TARGET THERAPEUTIC RANGE IS 2.5 - 3.0. ON (B)(6) 2011, THE LAB RESULT WAS DONE AT 12:00 PM AND THE INRATIO RESULT WAS DONE AT 12:50 PM. PT'S PHYSICIAN INSTRUCTED HER TO EAT SPINACH AFTER HER (B)(6) 2011 RESULT, THEN TO RETEST, AND GO TO THE LAB FOR A COMPARISON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1