BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO/INRATIO2 TEST STRIPS

    MDR report key: 3830026 · Received March 13, 2014

    Report

    Report Number
    2027969-2014-00224
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    March 2, 2014
    Report Date
    March 2, 2014
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVAL. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. IMPROPER TECHNIQUES AND IMPROPER USE OF THE METER WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, RETAIN TESTING WAS PERFORMED DURING AN IN-HOUSE INVESTIGATION. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MFG RECORDS FOR THE LOT WERE REVIEWED AND THERE WERE NO ISSUES RELATED TO THIS COMPLAINT NO FURTHER INVESTIGATION WAS PERFORMED. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO INR RESULTS. RESULTS ARE AS FOLLOWS: DATE (B)(6) 2014, INRATIO INR 6.4, 1.1 AND 3.3. THE TIME BETWEEN EACH TEST WAS FIVE (5) MINUTES. REPORTEDLY, THE METER WAS NOT IN THE CORRECT MODE WHEN FINGER STICK WAS PERFORMED, THE FINGER WAS "MILKED" AFTER THE FINGER STICK, MULTIPLE DROPS OF BLOOD WAS APPLIED AND THE SAMPLE WAS NOT APPLIED IMMEDIATELY AFTER THE FINGER STICK. THERAPEUTIC RANGE 2.0 - 3.0 FOR THE 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
    150796 INRATIO/INRATIO2 TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 332830

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR: SN (B)(4)| COUMADIN