BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALERE INR RATIO 2

    MDR report key: 4398674 · Received December 31, 2014

    Report

    Report Number
    MW5040054
    Event Type
    Other
    Date Received
    December 31, 2014
    Date of Event
    December 16, 2014
    Report Date
    December 31, 2014
    Manufacturer
    ALERE
    Product Code
    GJS
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A FORM WARNING OF POSSIBLE INCORRECT READINGS FROM ALERE PT/INR MONITOR SYSTEM. I WAS IN THE SAFE PARAMETERS FOR HEMATOCRIT. HAD NO OTHER HEALTH ISSUES LISTED. CONFIRMED INR WITH LAB VEINOUS DRAW AND FROM ALERE MONITOR. ALL WITHIN RANGE. SO NO ACTION NEEDED AND SAFE TO CONTINUE TO USE THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862891 ALERE INR RATIO 2 PT/INR RATIO GJS ALERE CE0197

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR