BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3678573 · Received February 19, 2014

    Report

    Report Number
    2027969-2014-00135
    Event Type
    Death
    Date Received
    February 19, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 23, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO THE LABORATORY RESULT. PT IS A (B)(6) OLD MALE WHO WAS RECENTLY HOSPITALIZED ON (B)(6) 2014 FOR EFFUSION AND LUNG MASS AND DIAGNOSED WITH METASTATIC SMALL CELL LUNG CARCINOMA. ON (B)(6) 2014 AT 5:15PM, THE PT'S INRATIO INR RESULT WAS 2.8 AND WARFARIN 3MG WAS ADMINISTERED. REPORTEDLY, THE FINGER WAS "MILKED" AFTER THE FINGER STICK AND THE SAMPLE WAS NOT IMMEDIATELY APPLIED. THE PT'S THERAPEUTIC WAS 2.0 - 3.0. AT 8:15PM, THE PT EXPERIENCED WHAT WAS DESCRIBED AS "MASSIVE HEMOPTYSIS". THE PT WAS INTUBATED WHILE EN ROUTE TO THE EMERGENCY ROOM. THE LABORATORY INR AT 10:40PM WAS 7.6, HEMOGLOBIN = 12.2 AND HEMATOCRIT = 37.5 (PRIOR TO BLOOD TRANSFUSION). THE PT WAS HOSPITALIZED ON A VENTILATOR IN ICU, ADMINISTERED VITAMIN K, 3 UNITS OF FRESH FROZEN PLASMA (FFP), 2 UNITS OF BLOOD, ANTIBIOTICS AND PRESSORS AS NEEDED FOR HYPOTENSION. CT SCAN OF THE BRAIN REVEALED NO ACUTE CHANGES. CT SCAN OF THE CHEST REVEALED NO PULMONARY EMBOLISM (PE) BUT LUNG MASS AND POSSIBLE BILATERAL PROCESS. AFTER PT TREATMENT, THE LABORATORY INR WAS 1.8. ON (B)(6) 2014 DUE TO THE PT'S POOR PROGNOSIS, TERMINAL CANCER AND HIS WISHES TO NOT HAVE TO GO THROUGH FURTHER INVASIVE MEDICAL CARE, THE PT WAS PLACED ON A MORPHINE DRIP AND THE PRESSORS (PROPOFOL) WAS DISCONTINUED. THE PT'S AICD WAS TURNED TO "NO SHOCK", THE PT WAS EXTUBATED AND EXPIRED AT 6:47 PM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104297 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2 324810

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H| R AMIODARONE HCL 200MG DAILY| ASPIRIN 81MG DAILY| INRATIO 2 PT/INR PRO MONITOR SN (B)(4) WARFARIN| COREG 6.25MG TWICE A DAY| LASIX 60MG DAILY DATE OF TX (B)(6) 2014| LANOXIN 0.125MG DAILY| CAPTOPRIL 6.25MG TWICE A DAY