BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO PT/INR

    MDR report key: 4810404 · Received May 27, 2015

    Report

    Report Number
    MW5042868
    Event Type
    Other
    Date Received
    May 27, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    ALERE
    Product Code
    GJS
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS PRESCRIBED AN ALERE INRATIO PT/INR MONITORING SYSTEM. PRESCRIPTION WAS NEVER FILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343313 INRATIO PT/INR INRATIO PT/INR GJS ALERE

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR