BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2148605 · Received June 27, 2011

    Report

    Report Number
    2027969-2011-01406
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAS APS. PATIENT CURRENT HEALTH STATUS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR. 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 = 3.0, REFERENCE = 2.3, MEAN = 2.65, CONFIDENCE LIMITS = 1.7 - 3.8. 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. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET ACCURACY CRITERIA. AS REVIEWED ON (B)(6) 2011, 123 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #241836 YIELDING A COMPLAINT RATE OF 0.131%. ACTION THRESHOLD (>0.07%) HAS BEEN REACHED. SINCE STRIP LOT WAS RELEASED, (B)(4). CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE TEST. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE REQUIREMENTS WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. 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: DATE: (B)(6) 2011, INRATIO: 3.0, LAB: 2.3. TESTS WERE DONE AT THE SAME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1