BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4171038 · Received July 14, 2014

    Report

    Report Number
    2027969-2014-00658
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVAL. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING DATA WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURN TESTING, IMPROPER TECHNIQUE WAS IDENTIFIED IN THE COMPLAINT. THIS COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. THE MFG 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 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: 1.5, 3.9, 4.4, AND 3.6. THERAPEUTIC RANGE: 2.0-2.9. THE TESTING WAS PERFORMED WITHIN FIFTEEN (15) - TWENTY (20) MINUTES. REPORTEDLY THE FINGER WAS TOUCHED TO THE SAMPLE WELL. 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
    410581 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 033862

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN 5 MG 3X WEEKLY AND 2.5 MG 4X WEEKLY,| LEVOQUIN (RECENTLY COMPLETED)| INRATIO MONITOR SN UNK,