BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 4603676 · Received March 4, 2015

    Report

    Report Number
    MW5041380
    Event Type
    Other
    Date Received
    March 4, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 4, 2015
    Manufacturer
    ALERE
    Product Code
    GJS
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ALERE HOME MONITORING IS REPLACING THE RECALLED INRATIO METER WITH ANOTHER MANUFACTURER'S METER. THEY ARE FAILING TO PROVIDE ANY TRAINING TO PATIENTS ON THESE NEW METERS. FDA GUIDELINES REQUIRE TRAINING FOR PATIENTS USING HOME INR METERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149384 INRATIO INRATIO GJS ALERE

    Patients

    Seq Age Sex Outcome Treatment
    1