BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3240898 · Received July 17, 2013

    Report

    Report Number
    2027969-2013-00574
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2013, INRATIO: 6.8 AND 2.4, MEAN: 4.60, SD: 3.11, %CV: 67.64. INRATIO METER RESULTS FAILED THE CRITERIA FOR PRECISION, GENERATING A %CV GREATER THAN 20%. IN-HOUSE THERAPEUTIC DONOR TESTING WAS PERFORMED ON REPORTED LOT # 305275 ON (B)(6) 2013. RESULTS WERE AS FOLLOWS: DONOR (B)(4): 235, INRATIO: 2.5, 2.7, 2.5, REFERENCE: 3.08, BIAS THRESHOLD: 2.08 - 4.08, %CV: 4.50; DONOR (B)(4): 217, INRATIO: 2.7, 2.7, 2.6, REFERENCE: 2.23, BIAS THRESHOLD: 1.23 - 3.23, %CV: 2.17. RETENTION PRODUCTS PERFORMED AS EXPECTED. ALL REPLICATES WERE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY AND YIELDED A %CV OF LESS THAN 16%, PASSING THE PRECISION CRITERIA. NO FURTHER INVESTIGATION WAS 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 ACCURACY AND PRECISION CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. (B)(4) DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #305275, YIELDING A COMPLAINT RATE OF (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD 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 INRATIO2 INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013, INRATIO2 INR: 6.8 AND 2.4. THE TIME BETWEEN TESTING WAS MINUTES. THERAPEUTIC RANGE IS 2.0-3.0 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
    332809 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 305275

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN