BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2134792 · Received May 16, 2011

    Report

    Report Number
    2027969-2011-01086
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST RESULTS WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 3.3, REF: 2.5, MEAN: 2.9, CONFIDENCE LIMITS: 1.8 - 4.2, RESULT: PASS. DATE: (B)(6) 2011, INRATIO: 5.6, REF: 4.6, MEAN: 5.1. UNABLE TO DETERMINE INR ACCURACY CONFIDENCE LIMITS FOR CALCULATED MEAN GREATER THAN 5.0. ACCURACY DETERMINATIONS ARE NOT DEFINED FOR RESULTS THAT EXCEED THIS THRESHOLD. FURTHER TESTING IS REQUIRED. ALL OTHER REPORTED RESULTS ARE WITHIN THE CONFIDENCE LIMITS FOR PASSING ACCURACY COMPARISON. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. USER REPORTED CONCERNS WITH RECENT MEDICATION AND IT'S POTENTIAL AFFECTS ON INR TESTING. INSUFFICIENT INFORMATION TO DETERMINE IF THIS PRESENTED INTERFERENCE. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 241836 ON (B)(6) 2011. RESULTS AS FOLLOWS: INRATIO: 2.4, INRATIO: 2.7, INRATIO: 2.8, REFERENCE: 2.82, BIAS: 1.82, THRESHOLD: -3.82. INRATIO: 2.9, INRATIO: 3.0, INRATIO: 2.7, REFERENCE: 2.56, BIAS: 1.56, THRESHOLD: -3.56. THE MINIMUM TWO OUT OF THREE REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. NO FURTHER INVESTIGATION IS NECESSARY. PATIENT'S CONDITIONS MAY HAVE CONTRIBUTED TO UNEXPECTED RESULTS. HEMATOCRIT LEVEL WAS NOT AVAILABLE. 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, 104 DISCREPANT RESULTS COMPLAINT WERE REPORTED FOR LOT #241836 YIELDING A COMPLAINT RATE OF 0.111%. ACTION THRESHOLD HAS REACHED. SINCE STRIP LOT RELEASED, 7 IN-HOUSE THERAPEUTIC SAMPLE TESTS WITH 21 STRIPS HAVE BEEN PERFORMED FOR RETAINED AND RETURN STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE 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

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: 3.3, LAB: 2.5. DATE: (B)(6) 2011, INRATIO: 5.6, LAB: 4.6. PATIENT'S TARGET THERAPEUTIC RANGE IS: 3-3.5. LAB RESULTS DONE 15 MINUTES AFTER METER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1