BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 11819094 · Received May 13, 2021

    Report

    Report Number
    3010606081-2021-00010
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 18, 2021
    Report Date
    May 13, 2021
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON APRIL 18TH, THE USER CONTACTED DARIO TO REPORT AN ELEVATED BLOOD GLUCOSE (BG) READING OF 440 MG/DL. DUE TO THIS ELEVATED READING, THE USER WENT TO URGENT CARE WHERE HER BG LEVEL WAS TESTED. THE USER RECEIVED A BG READING OF 106 MG/DL WITH THE FACILITY'S NON-DARIO DEVICE. THE DOCTOR AT THE URGENT CARE FACILITY TOLD THE USER THAT HE IS QUESTIONING WHETHER THE DARIO METER WAS WORKING PROPERLY. MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE USER WERE MADE, HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THERE IS NOT ENOUGH INFORMATION AVAILABLE TO FURTHER INVESTIGATE THIS CASE. THEREFORE, NO RESOLUTION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714683 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other