BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1982571 · Received January 11, 2011

    Report

    Report Number
    2027969-2011-00073
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: 3.1, REFERENCE: 2.3, MEAN: 2.70, CONFIDENCE LIMITS: 1.7-3.8. THE 2.1 INR WAS EXCLUDED FROM COMPARISON TEST SINCE NO CORRESPONDING REFERENCE OR REPEATED INRATIO VALUE WAS PROVIDED. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID 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 SOMETIMES MILKS THE FINGER. PER PRODUCT USER GUIDE, MILKING THE FINGER RELEASES INTERSTITIAL FLUIDS AND MAY CAUSE INACCURATE INR RESULTS. PATIENT'S CURRENT HEALTH CONDITION AND LIST OF MEDICATIONS MAY HAVE ALSO AFFECTED COAGULATION TESTING AND LED TO THE UNEXPECTED INR RESULTS. AS REVIEWED ON (B)(4) 2011, THIRTY DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #243934, YIELDING A COMPLAINT RATE OF 0.022%. 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: 3.1, LAB: 2.3. DATE: (B)(6) 2010, INRATIO: 2.1, LAB: NG. PATIENT'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. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI