BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 18107545 · Received November 9, 2023

    Report

    Report Number
    3010606081-2023-00068
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    October 11, 2023
    Report Date
    October 11, 2023
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING TROUBLESHOOTING ON THE PHONE WITH DARIO'S REPRESENTATIVE, A REPLACEMENT OF DARIO'S STRIPS AND CONTROL SOLUTION WAS SENT TO THE USER TO MAKE SURE THAT THE DARIO STRIPS ARE READING CORRECTLY, AND TO ENSURE PROPER TECHNIQUE. AFTER THE NEW DARIO STRIPS AND CONTROL SOLUTION WERE RECEIVED, THE USER CONTACTED DARIO IN ORDER TO PERFORM THE CONTROL SOLUTION TEST WITH DARIO'S REPRESENTATIVE. THE USER'S DARIO METER WAS TESTED WITH CONTROL SOLUTION AND A NEW CARTRIDGE OF STRIPS: THE METER READ WITHIN RANGE FOR BOTH TESTS. CONTROL SOLUTION LEVEL 1 TEST RESULTS WAS 135 MG/DL (RANGE 107-155 MG/DL). CONTROL SOLUTION LEVEL 2 TEST RESULTS WAS 231 MG/DL (RANGE 183-264 MG/DL). IN ADDITION, THE USER TESTED HER BG LEVEL AND RECEIVED A READING THAT WAS WITHIN 10 MG/DL DIFFERENCE WHEN COMPARED TO HER NON-DARIO METER AND THE USER'S CGM. THIS DIFFERENCE IS CONSIDERABLE WHEN COMPARED BETWEEN TWO DIFFERENT METERS OR DEVICES. THE USER'S ISSUE WAS RESOLVED WITH THE NEW CARTRIDGE OF STRIPS. THERE IS NOT ENOUGH INFORMATION AVAILABLE REGARDING THE DARIO METER AND STRIPS TO INVESTIGATE. NO RESOLUTION IS AVAILABLE.

    Description of Event or Problem · 0

    ON OCTOBER 11TH, 2023, THE USER CONTACTED DARIO TO REPORT A HIGH BLOOD GLUCOSE (BG) READING. THE USER REPORTED RECEIVING A BG READING OF 320 MG/DL WITH HER DARIO METER COMPARED TO A BG READING OF 100 MG/DL FROM BOTH HER NON-DARIO METER AND HER CGM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112212 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other