BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO 2

    MDR report key: 5910084 · Received August 25, 2016

    Report

    Report Number
    MW5064374
    Event Type
    Other
    Date Received
    August 25, 2016
    Date of Event
    January 1, 2016
    Report Date
    August 25, 2016
    Manufacturer
    ALERE
    Product Code
    GJS
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER COMPLAINED THAT THE MACHINE WAS RECALLED BY THE MANUFACTURER AND HE IS NOT BEING COMPENSATED FOR THE COST HE INCURRED IN PURCHASING IT. THE FDA SHOULD DO SOMETHING ABOUT THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554560 INRATIO 2 PT/INR MONITOR GJS ALERE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR