BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALERE INRATIO MONITOR SYSTEM

    MDR report key: 4737430 · Received April 23, 2015

    Report

    Report Number
    MW5042342
    Event Type
    Other
    Date Received
    April 23, 2015
    Report Date
    April 23, 2015
    Manufacturer
    ALERE
    Product Code
    GJS
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INRATIO MACHINE NOT GIVING TRUE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271235 ALERE INRATIO MONITOR SYSTEM PT/INR MONITOR GJS ALERE

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR