BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALERE INRATIO METER

    MDR report key: 5690682 · Received May 25, 2016

    Report

    Report Number
    MW5062534
    Event Type
    Death
    Date Received
    May 25, 2016
    Date of Event
    February 10, 2016
    Report Date
    May 25, 2016
    Manufacturer
    ALERE
    Product Code
    GJS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOME HEALTH NURSE HAD BEEN MONITORING (B)(6)'S COUMADIN LEVELS BY USING ALERE INRATIO METER AND STRIPS. WE WERE NOTIFIED THAT A REGULAR BLOOD DRAW FROM THE ARM SHOWED A LEVEL OF 8 EVEN THOUGH PREVIOUS METER READINGS HAD REGISTERED IN NORMAL LEVEL. THIS BLOOD DRAW WAS ON (B)(6) 2016 AND A F/U BY THE ALERE METER SHOWED A 1.7. MR. (B)(6) WAS ADMITTED TO THE HOSPITAL WITH A BRAIN BLEED ON (B)(6) 2016 AND DIED AS A RESULT OF THE BLEED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332608 ALERE INRATIO METER ALERE INRATIO METER GJS ALERE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H