BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3853169 · Received April 2, 2014

    Report

    Report Number
    2027969-2014-00287
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, RETAIN TESTING ON INRATIO STRIPS WAS PERFORMED DURING AN IN-HOUSE INVESTIGATION. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCTS PERFORMED AS EXPECTED AND PRODUCT DEFICIENCIES WERE NOT OBSERVED. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THERE WERE NO ISSUES RELATED TO THIS COMPLAINT. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. BASED ON THE INFORMATION 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: 1.4, 2.3, 2.3. THE TIME BETWEEN TESTING WAS WITHIN MINUTES. CUSTOMER IS A LONG TIME USER OF THE INRATIO SYSTEM AND HAS BEEN A LONG TIME USER OF THE MICROSAFE TUBES FOR SAMPLE APPLICATION. SINCE THE MICROSAFE TUBES ARE NO LONGER VALIDATED FOR USE, THE FACILITY HAS HAD SOME ISSUES WITH DIRECT SAMPLE APPLICATION. EXACT TECHNIQUE WAS NOT PROVIDED FOR EACH OF THESE TEST RESULTS. CUSTOMER DID EXPRESS DIFFICULTY WITH SAMPLE APPLICATION AND THE SAMPLE WAS NOT IMMEDIATELY APPLIED AFTER THE FINGER STICK. 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
    200529 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2 333865

    Patients

    Seq Age Sex Outcome Treatment
    1