BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTEL CARE

    MDR report key: 11706175 · Received April 21, 2021

    Report

    Report Number
    MW5100930
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 20, 2021
    Manufacturer
    TELCARE, LLC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BIOTEL CARE METER. REMOTELY DISABLED BY BIOTEL/ONDUO, ALSO RECEIVED A VOICEMAIL STATING AN ISSUE WITH IT. IT KEEPS POPPING UP "INTERNET CONNECTION REQUIRED" NO MATTER WHAT FUNCTION I USE (DESPITE SHOWING STRONG "4G" SIGNAL), INCLUDING WHEN I INSERT A GLUCOSE TEST STRIP. GOT RID OF OLD TRUE METRIX METER AFTER RECEIVING THIS ONE FROM EMPLOYER, SO I HAVE NO BACKUP GLUCOSE METER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601953 BIOTEL CARE SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW TELCARE, LLC 59106000928

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Disability