BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 3243025 · Received July 18, 2013

    Report

    Report Number
    2027969-2013-00587
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 10, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER COMPLAINT WAS FILED: DATE: (B)(6) 2013, INRATIO METER = 1.7 INR, REFERENCE = 3.9 INR, MEAN = 2.80, CONFIDENCE LIMITS = 1.7 - 3.8. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. REFERENCE VALUE FALLS OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 291809 ON (B)(6) 2013. RESULTS AS FOLLOWS: DONOR: (B)(6) INRATIO: 2.0, INRATIO: 2.0, INRATIO: 2.0, REF.: 1.84, BIAS-THRESH.: 1.34 - 2.34, %CV: 0; DONOR: (B)(6), 1.7, 1.7, 1.7, 1.66, 1.16 - 2.16, 0. ALL REPLICATES FOR EACH DONOR WERE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN 16%. ACCURACY AND PRECISION CRITERIA HAVE BEEN MET. NO FURTHER INVESTIGATION IS NECESSARY. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND PRECISION CRITERIA. PRODUCT PERFORMED AS EXPECTED. AS REVIEWED ON (B)(4) 2013, (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 ACCURACY RESULTS WHEN COMPARED TO THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 1.7, LAB: 3.9. TIME BETWEEN TESTING WAS REPORTED IS UNKNOWN. PATIENT'S THERAPEUTIC RANGE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335308 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 291809

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| INCREASED THE WEEK PRIOR AFTER OBTAINING,| INR = 1.9 RESULT.