BEUDAMED
    FDA Adverse Event Summary report: N

    INRATIO

    MDR report key: 2027447 · Received February 10, 2011

    Report

    Report Number
    2027969-2011-00467
    Date Received
    February 10, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 5.8 INR, REFERENCE: 4.1 INR, MEAN: 4.95, CONFIDENCE LIMITS: (2.8 - 7.2); DATE: (B)(6) 2011, INRATIO: 5.8 INR, REFERENCE: 4.0 INR, MEAN: 4.90, CONFIDENCE LIMITS: (2.8 - 7.2). 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. PT WAS MILKING THE FINGER WHICH MAY CAUSE CONTAMINATION WITH INTERSTITIAL FLUIDS AND MAY LEAD TO INACCURATE INR RESULT OR TESTING ERROR. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. RETAINED STRIP TEST RECORD HAS BEEN REVIEWED. TEST RESULT COMPARISON MET PRODUCT PERFORMANCE CRITERIA. (B)(4) ACTION THRESHOLD HAS REACHED. SINCE STRIP LOT RELEASED, IN-HOUSE THERAPEUTIC SAMPLE TESTS WERE PERFORMED FOR RETAIN AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN TEST. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. 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 AND DR'S POINT OF CARE (POC). RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO INR: 5.8, LAB INR: 4.1, DR'S POC INR: 4.0. PT'S TARGET RANGE: 2.5 - 3.5. PT DID HAVE TO MILK FINGER TO GET SAMPLE.

    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