BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2004526 · Received February 23, 2011

    Report

    Report Number
    2027969-2011-00388
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 METER = 4.5; REFERENCE = 2.7; MEAN = 3.6; CONFIDENCE LIMITS = 2.0 - 5.0. DATE: (B)(6) 2011; INRATIO METER = 3.2; REFERENCE = 2.7; MEAN = 2.95; CONFIDENCE LIMITS = 1.8 - 4.2. 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. NO FURTHER INVESTIGATION IS REQUIRED. AS REVIEWED ON 02/20/2011, 60 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT # 233029 YIELDING A COMPLAINT RATE OF 0.1%. 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. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011; INRATIO: 4.5; LAB: 2.7. DATE: (B)(6) 2011; INRATIO: 3.2; LAB: 2.7. PT'S THERAPEUTIC RANGE IS 2.0-3.0; HE'S USUALLY BETWEEN 2.3-2.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100071 233029

    Patients

    Seq Age Sex Outcome Treatment
    1