BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTOUCH GLUCOSE MONITORING SYSTEM

    MDR report key: 7603736 · Received June 14, 2018

    Report

    Report Number
    3005798905-2018-00597
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    May 15, 2018
    Report Date
    June 14, 2018
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    NBW
    PMA / PMN Number
    K073492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT RECEIVED NEW METER AND IT WAS WORKING GREAT FOR THE FIRST 2 WEEKS AND ALL OF A SUDDEN IT CONTINUES TO READ ERROR ON THE SCREEN PATIENT WAS ASKED IF THERE WAS A NUMBER AFTER THE ERROR AND SHE STATED NO, ITS EITHER JUST ER OR ERR. PATIENT'S CAREGIVER(S) DO NOT FEEL COMFORTABLE WITH THIS PRODUCT AND WANT TO RETURN THE PRODUCT. PATIENT'S BLOOD SUGAR DROPPED SO LOW SHE HAD TO BE TAKEN TO THE HOSPITAL. PATIENT'S CAREGIVER(S) WERE UNAWARE BLOOD SUGAR HAD DROPPED SO LOW DUE TO THE METER NOT FUNCTIONING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446548 EASYTOUCH GLUCOSE MONITORING SYSTEM GLUCOSE METER NBW MHC MEDICAL PRODUCTS, LLC 463703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization