BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1972733 · Received January 21, 2011

    Report

    Report Number
    2027969-2011-00159
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 21, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    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: 1.1; REFERENCE: 1.7; MEAN: 1.40: CONFIDENCE LIMITS: 1.1-1.9. INRATIO: 3.0; 2.6; 2.80; 1.7-3.8. 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, CUSTOMER USED THE SAME FINGERSTICK FOR TESTINGS DONE ON (B)(6) 2010. RE-STICKING THE SAME SITE MAY HAVE CAUSED PRE-ANALYTICAL ERRORS IN FINGERSTICK. IN ADDITION, PT WAS ALSO TAKING SEVERAL MEDICATIONS. PER PRODUCT USER GUIDE, CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS CAN AFFECT THE ACTIONS OF ORAL COAGULANTS AND MAY LEAD TO INACCURATE INR RESULTS. AS REVIEWED ON 01/21/2011, NINE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #235740, YIELDING A COMPLAINT RATE OF 0.002%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), 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

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INRATIO: 1.1; LAB: 1.7: (B)(6) 2010; 3.0; 2.6. PT'S COUMADIN DOES WAS SLIGHTLY INCREASED DUE TO BOTH READINGS ON (B)(6) 2010. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 235740

    Patients

    Seq Age Sex Outcome Treatment
    1 NI