BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 11633785 · Received April 8, 2021

    Report

    Report Number
    3010606081-2021-00007
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 8, 2021
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON MARCH 12TH, THE USER CONTACTED DARIO TO REPORT ELEVATED BLOOD GLUCOSE (BG) READINGS. THE USER WENT TO THE DOCTOR, WHERE HE COMPARED HIS BG LEVELS WITH HIS DOCTOR. THE USER ALSO REPORTED COMPARING HIS BG LEVELS WITH HIS VISITING NURSE. IN BOTH CASES, THE USER RECEIVED READINGS 25-35 MG/DL LOWER THAN THE USER'S DARIO METER. IN ADDITION, THE USER REPORTED THAT ON TWO OCCASIONS, HIS BG LEVEL WAS IN THE 50S MG/DL AND THE DARIO METER READ IN THE RANGE OF HIGH 70 MG/DL TO LOW 80 MG/DL. 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
    535744 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other