BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 3853089 · Received May 23, 2014

    Report

    Report Number
    2027969-2014-00481
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. 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. THE MANUFACTURING RECORDS FROM THE LOT WERE REVIEWED. THE LOT MET SPECIFICATIONS AND NO NON-CONFORMANCES WERE DOCUMENTED. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTED ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE - (B)(6) 2014; INRATIO - 2.9; LAB > 90 (PT RESULT - NO INR PROVIDED). THERAPEUTIC RANGE: 2.0 - 3.0. CUSTOMER WAS NOT THE INDIVIDUAL WHO RAN THE TEST AND WAS UNABLE TO PROVIDED INFORMATION REGARDING TECHNIQUE. THE CUSTOMER PROVIDED INFORMATION REGARDING TECHNIQUE. THE CUSTOMER PROVIDED SERIAL NUMBERS FOR TWO INRATIO METERS BECAUSE THEY WERE UNSURE OF WHICH METER WAS GIVING DISCREPANT RESULTS. PATIENT WAS HOSPITALIZED ON (B)(6) 2014 FOR A CLOT IN HIS CATHETER. UPON ADMISSION , PATIENT WAS ADMINISTERED 10 MG OF INTRAVENOUS VITAMIN K. INR WAS TESTED IN THE LAB ON (B)(6) 2014; THE RESULT WAS A 2.4 (12:50 AM) AND 1.6 (9:46 AM). AFTER 1.6 READING, PATIENT WAS DISCHARGED AND ALLOWED TO UNDERGO DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309136 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 340875

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention WARFARIN| THE SN FOR TWO MONITORS: (B)(4)