BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2082600 · Received April 27, 2011

    Report

    Report Number
    2027969-2011-00945
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF (B)(6) 2011, NO PRODUCT IS EXPECTED TO RETURN NOR STRIP LOT INFO PROVIDED. UNABLE TO PERFORM IN-HOUSE INVESTIGATION. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 1.4, REFERENCE: 2.1, MEAN: 1.75, CONFIDENCE LIMITS: 1.2 - 2.7; DATE: (B)(6) 2011, INRATIO: 1.6, REFERENCE: 1.9, MEAN: 1.75, CONFIDENCE LIMITS: 1.2 - 2.7. THE 3.4 INR IS EXCLUDED FROM COMPARISON TEST DUE TO PENDING INR LAB RESULT. 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 NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. NO STRIP LOT INFO WAS AVAILABLE. NO PRODUCT WAS EXPECTED TO BE RETURNED. 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. PT IS ON AMIODARONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1