BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 19749386 · Received July 16, 2024

    Report

    Report Number
    3010606081-2024-00043
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 11, 2024
    Report Date
    June 11, 2024
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    UDI-DI
    00850065006253
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER WAS USING A CARTRIDGE OF STRIPS THAT EXPIRED IN JANUARY 2024. DARIO'S USER GUIDE STATES IN THE SECTION FACTORS THAT MAY LEAD TO INACCURATE RESULTS: "THE TEST STRIP IS EXPIRED." AND IN THE TEST STRIP PRECAUTIONS SECTION: "CHECK THE "USE BY" DATE ON THE TEST STRIP CARTRIDGE. DO NOT USE THE TEST STRIPS AFTER THAT DATE". A REPLACEMENT OF DARIO'S STRIPS WAS SENT TO THE USER TO MAKE SURE THAT THE DARIO STRIPS ARE READING CORRECTLY. AFTER THE ABOVE WAS RECEIVED, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER. THE USER REPORTED THAT ALTHOUGH HE RECEIVED THE NEW CARTRIDGE OF STRIPS, HE DIDN'T OPEN THEM YET. INSTEAD, THE USER REPORTED THAT HE OPENED AND TESTED WITH A NEW CARTRIDGE OF STRIPS THAT HE HAD AT HOME, THAT WERE NOT EXPIRED, AND HE RECEIVED BG READINGS WITHIN HIS NORMAL RANGE. SINCE THE USER'S BG READING ISSUE WAS RESOLVED WITH NEW STRIPS, THEREFORE, IT CAN BE DETERMINED THAT THERE WAS MISUSE OF THE STRIPS. THIS COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A BG READING OF 77 MG/DL FOLLOWED BY A BG READING OF 121 MG/DL FROM HIS DARIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507023 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD. NA 00850065006253

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other