BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3025201 · Received March 19, 2013

    Report

    Report Number
    2027969-2013-00222
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: INRATIO, REFERENCE MEAN, CONFIDENCE LIMITS: (B)(6) 2013, 1.0, 2.5, 1.75, 1.2 - 2.3. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WAS CALCULATED. BOTH INRATIO AND REFERENCE VALUES FALL OUTSIDE THE LIMITS, SO THE CRITERIA ARE 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. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 296804 ON (B)(6) 2013. RESULTS AS FOLLOWS: DONOR: 212, INRATIO: 2.1, 212, 212, REFERENCE: 2.09, BIAS THRESHOLD: 1.09 - 3.09, %CV: 2.66. DONOR: 215, INRATIO: 2.4, 2.4, 2.4, REFERENCE: 2.21, BIAS THRESHOLD: 1.21 - 3.21, %CV: 0.00. ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN 16%.PRECISION CRITERIA HAS BEEN MET. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED SO RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RETAIN STRIP TESTING RESULTS MET ACCURACY AND PRECISION CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4)) 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 INRATIO INR RESULTS IN COMPARISON TO THE LABORATORY INR RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO INR: 1.0, LABORATORY INR: 2.5. THE TIME BETWEEN TESTING WAS LESS THAN FIVE MINUTES. THERAPEUTIC RANGE WAS NOT PROVIDED FOR THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114838 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 296804

    Patients

    Seq Age Sex Outcome Treatment
    1 PLAVIX| COUMADIN/WARFARIN