BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH GLUCOSE METER KIT

    MDR report key: 7628135 · Received June 21, 2018

    Report

    Report Number
    3005798905-2018-02666
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    February 8, 2018
    Report Date
    June 20, 2018
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    NBW
    PMA / PMN Number
    K073492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    READINGS ARE IN THE 300'S. CONTROL SOLUTION RANGE LOW = 29-59; LOW READING = 51. CONTROL SOLUTION RANGE HIGH = 253-343; HIGH READING = 285.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468046 EASYTOUCH GLUCOSE METER KIT SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW MHC MEDICAL PRODUCTS, LLC 807001

    Patients

    Seq Age Sex Outcome Treatment
    1