BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO METER

    MDR report key: 4609578 · Received March 12, 2015

    Report

    Report Number
    MW5041473
    Event Type
    Death
    Date Received
    March 12, 2015
    Date of Event
    March 21, 2014
    Report Date
    February 27, 2015
    Manufacturer
    ALERE
    Product Code
    GJS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    (B)(6) PASSED AWAY DUE TO COMPLICATIONS OF EMBOLIC STROKE. (B)(6) WAS ON WARFARIN, BLOOD THINNER MEDICINE SINCE HE HAD THE AORTIC VALVE REPLACED IN 2005. THE RECALLED MEDICAL DEVICES, (IN RATION MONITOR AND INR STRIPS) WERE MEASURING THE AMOUNT OF MEDICINE IN THE BLOOD ENCLOSED PLEASE FIND A COPY OF DEATH CERTIFICATE, LETTER FROM THE REMOTE CARDIAC SERVICES REQUESTING NOT TO USE IN RATIO METER NOR INR STRIPS ANYMORE, COPY OF THE CHECK ALERE (B)(4), PAID WIFE (B)(6) FOR THE RETURNED IN RATIO METER AND INR STRIPS, AND NUMBERS OF THE RETURNED PRODUCTS. PLEASE INFORM WIFE (B)(6) WHETHER THERE IS A CLASS ACTION LAWSUIT AGAINST THE MANUFACTURER ALERE (B)(4). AND THE LAW FIRM WHICH HANDLES THE CASE. PLEASE KEEP MY NAME CONFIDENTIAL. THANK YOU. (B)(6). DOSE OR AMOUNT: ONE OR TWO TIMES A WEEK. DATES OF USE: FROM 2006 TO (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169713 INRATIO METER PT/INR MONITOR GJS ALERE M304010013931
    169714 INRATIO METER PT/INR MONITOR GJS ALERE 080160400
    169715 INRATIO STRIPS PT/INR STRIPS GJS ALERE 09678494
    169716 INRATIO STRIPS PT/INR STRIPS GJS ALERE 9900892 K318141

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death