BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 11818928 · Received May 13, 2021

    Report

    Report Number
    3010606081-2021-00009
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 16, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), THE USER CONTACTED DARIO TO REPORT A HIGH BLOOD GLUCOSE (BG) READING. DUE TO THIS ELEVATED READING, THE USER WENT TO THE ER, WHERE HER BG LEVEL WAS TESTED WITH THE HOSPITAL'S METER AND WAS FOUND TO READ LOWER THAN THE USER'S DARIO METER. THE USER REPORTED THAT SHE HADN'T USED THE METER FOR A WHILE. WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER HAD BEEN USING A CARTRIDGE OF STRIPS THAT EXPIRED ALMOST 3 YEARS AGO (SEPTEMBER 2018). THIS CARTRIDGE OF STRIPS WAS ALSO OPENED A COUPLE OF YEARS AGO, AND THEREFORE WAS EXPIRED. DARIO'S USER GUIDE STATES IN THE SECTION REGARDING "FACTORS THAT MAY LEAD TO INACCURATE RESULTS", THAT THE USE OF STRIPS AFTER THE EXPIRATION DATE MAY LEAD TO INACCURATE RESULTS. MOREOVER, AS PER DARIO'S TEST STRIPS LABELING "USE WITHIN ONE MONTH FROM FIRST OPENING THE CARTRIDGE FOIL". DARIO'S REPRESENTATIVE EXPLAINED TO THE USER THAT STRIPS THAT HAVE BEEN OPENED FOR MORE THAN 30 DAYS CAN CAUSE INACCURATE READINGS. THE USER STATED THAT SHE DOES NOT HAVE ADDITIONAL STRIP CARTRIDGES AND DOES NOT WISH TO PURCHASE MORE. THE HIGH BG READINGS MAY HAVE BEEN DUE TO THE USE OF EXPIRED STRIPS. NOT ENOUGH INFORMATION REGARDING THE OLD STRIPS TO INVESTIGATE. NO OTHER PRODUCT PROBLEM WAS REPORTED. NO RESOLUTION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715949 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization