BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8013650

    MDR report key: 8013650 · Received October 29, 2018

    Report

    Report Number
    8013650
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 16, 2018
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    HOME INR MONITOR COMPARISON: PATIENT'S HOME INR MONITOR READ 2.1 AND THE LAB RESULT WAS 1.7. THIS DIFFERENCE IS CONCERNING BECAUSE IT MEANS THE DIFFERENCE IN NOT CHANGING THE TREATMENT PLAN (INR OF 2.1) AND TREATING THE PATIENT WITH LOVENOX AND ADJUSTING COUMADIN TO LOWER RISK FOR PUMP THROMBOSIS.

    Description of Event or Problem · 1

    HOME INR MONITOR COMPARISON: PATIENT'S HOME INR MONITOR READ 2.1 AND THE LAB RESULT WAS 1.7. THIS DIFFERENCE IS CONCERNING BECAUSE IT MEANS THE DIFFERENCE IN NOT CHANGING THE TREATMENT PLAN (INR OF 2.1) AND TREATING THE PATIENT WITH LOVENOX AND ADJUSTING COUMADIN TO LOWER RISK FOR PUMP THROMBOSIS.

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA