BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3164651 · Received June 7, 2013

    Report

    Report Number
    2027969-2013-00459
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INRATIO PRECISION DATA PROVIDED BY END-USER: (B)(6) 2013, INRATIO: 1.6 AND 3.0, MEAN: 2.30, SD; 0.99, %CV: 43.4. SINCE %CV EXCEEDS (B)(4), INRATIO METER RESULTS DO NOT PASS THE CRITERIA FOR PRECISION. FURTHER TESTING IS REQUIRED. THE LAST IN-HOUSE THERAPEUTIC DONOR TESTING PERFORMED ON REPORTED LOT K291549 ON (B)(4) 2013 YIELDED THE FOLLOWING RESULTS: DONOR: (B)(6), INRATIO: 1.9, 2.2, 2.2, REFERENCE 1.82, BIAS THRESHOLD: 1.32 - 2,32, %CV: 8.25; 202, 2.2, 2.2, 2.4, 2.25, 1.25 - 3.25, 5.09. ALL REPLICATES FOR EACH DONOR WERE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN (B)(4). PRECISION CRITERIA HAD BEEN MET. NO FURTHER INVESTIGATION REQUIRED. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO TESTING REVEALED THAT THE TEST RESULT COMPARISON DID NOT 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. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO 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. THERE IS NO CORRECTIVE ACTION AT THIS TIME, AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013, INRATIO INR: 1.6 AND 3.0. THE TIME BETWEEN TESTING WAS WITHIN MINUTES, USING DIFFERENT FINGERS. THERAPEUTIC RANGE 2.0-3.0 FOR PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253861 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 K291549

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN