BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 6309563 · Received February 7, 2017

    Report

    Report Number
    2027969-2017-00028
    Event Type
    Death
    Date Received
    February 7, 2017
    Date of Event
    December 1, 2016
    Report Date
    January 9, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Removal / Correction Number
    Z-2354,2362-2016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. IN-HOUSE TESTING ON THE RETURNED METER USING RETAINED TEST STRIPS MET ACCURACY CRITERIA. THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED. THE RETURNED METER PASSED FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING IN-HOUSE INVESTIGATION. THE SYSTEM PERFORMED WITHIN EXPECTATIONS. A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER AND THEREFORE A REVIEW OF MANUFACTURING RECORDS COULD NOT BE CONDUCTED. THE METER MEMORY WAS REVIEWED AND THE (B)(6) 2016 INRATIO INR RESULT OF 2.1 AS REPORTED BY THE WIFE WAS NOT LOCATED. THE LAST RESULT LOCATED IN THE METER MEMORY IS AN INR RESULT OF 1.37 ON (B)(6) 2016. A STATISTICAL ANALYSIS OF THE IMPEDANCE CURVES GENERATED USING THE LAST 4 INRATIO INR RESULTS STORED IN THE METER MEMORY DETERMINED THAT ONE OF THE CURVES EXHIBITED A WEAK-SLOPE. THE CUSTOMER WAS UNABLE TO CONFIRM WHICH RESULT WAS IN QUESTION, THEREFORE THE CURVE WITH THE WEAK-SLOPE COULD NOT BE CONFIRMED AS THE CUSTOMER'S COMPLAINT RESULT. WEAK-SLOPE CHANGES CAN CONTRIBUTE TO DISCREPANT RESULTS. THIS ISSUE IS RELATED TO THE ALGORITHM SOFTWARE ON THE METER AND WAS ADDRESSED IN A CAPA.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE CALLED IN RESPONSE TO INRATIO SYSTEM WITHDRAWAL NOTIFICATION. THE WIFE PROVIDED LAST HISTORICAL INRATIO INR RESULT OF 2.1 ON (B)(6) 2016. ALTHOUGH THE WIFE WAS UNABLE TO PROVIDE A THERAPEUTIC RANGE FOR THE PATIENT, SHE STATED THIS RESULT WAS IN RANGE. ON (B)(6) 2016: PATIENT SUFFERED A MAJOR STROKE, WAS ADMINISTERED A CLOT BUSTER, AND EXPERIENCED A SECOND STROKE. PATIENT DIED DUE TO ACUTE CVA WITH HEMORRHAGIC CONVERSION DUE TO OR AS A CONSEQUENCE OF IV TPA AND ATRIAL FIBRILLATION. NO ADDITIONAL INFORMATION AVAILABLE. ALTHOUGH A DEVICE DEFICIENCY CANNOT BE SUBSTANTIATED, THIS EVENT IS BEING CONSERVATIVELY FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90860 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| L| R INRATIO 2 PT MONITOR, PN 200432, SERIAL# (B)(4)