BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 3082586 · Received April 24, 2013

    Report

    Report Number
    2027969-2013-00337
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ALERE SAN DIEGO INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2013, 1ST INR: 1.1, 2ND INR: 1.0, MEAN: 1.05, SD: 0.07, %CV: 6.73. SINCE %CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH POC RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2013, 1ST INRATIO METER = 1.1, 2ND INRATIO METER = 1.0, REFERENCE = 2.4, MEAN = 1.5, CONFIDENCE LIMITS = 1.1 - 1.9. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE REFERENCE VALUED AND 2ND INRATIO METER VALUE FALL OUTSIDE THE LIMITS, THEREFORE THE CRITERIA WAS NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. THE LAST IN-HOUSE THERAPEUTIC DONOR TESTING PERFORMED ON REPORTED LOT 301621 ON (B)(4) 2013 YIELDED THE FOLLOWING RESULTS: INRATIO: DONOR (B)(6) 2.1, INRATIO: 2.3, INRATIO: 2.3, REF.: 2.17, BIAS-THRESH: 1.17 - 3.17, %CV: 5.17; DONOR (B)(6) 1.9, 2.1, 1.7, 2.35, 1.35 - 3.35, 10.53. ALL REPLICATES FOR EACH DONOR WERE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRECISION CRITERIA HAD BEEN MET. NO TECHNIQUE ERROR OBSERVED. NO FURTHER INVESTIGATION REQUIRED. ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO TESTS AND REFERENCE TESTS REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA BUT DID MEET PRECISION CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED SO RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND PRECISION CRITERIA. PATIENT WAS IDENTIFIED AS BEING ANEMIC. PATIENT'S CONDITION COULD HAVE CONTRIBUTED TO UNEXPECTED RESULTS. AS STATED IN THE PI, INRATIO HAS LIMITATION THAT HEMATOCRIT RANGES 30-55% HAVE BEEN SHOWN TO NOT AFFECT TEST RESULTS. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO 1: 1.1, INRATIO TEST 2: 1.0, ALT POC: 2.4. ALT POC WAS DR'S POINT OF CARE METER. TIME BETWEEN TESTING WAS REPORTED AS WITHIN AN HOUR. PATIENT'S THERAPEUTIC RANGE IS 2.0 - 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176172 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC. 100071 301621

    Patients

    Seq Age Sex Outcome Treatment
    1 METHA TREXATE| COUMADIN| IRON