BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

    MDR report key: 7576297 · Received June 6, 2018

    Report

    Report Number
    3005798905-2018-01745
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    July 28, 2017
    Report Date
    June 6, 2018
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER'S METER WILL NOT STAY ON. HE TRIED TO REPLACE THE BATTERIES, AND IF HE HOLDS HIS FINGER ON THE BATTERY IT COMES ON, BUT IF HE LETS GO, THE METER WILL SHUT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416626 SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW MHC MEDICAL PRODUCTS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1