BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 21053217 · Received January 2, 2025

    Report

    Report Number
    3010606081-2024-00075
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 4, 2024
    Report Date
    January 2, 2025
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    UDI-DI
    00850065006758
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER WAS USING A NEW CARTRIDGE OF STRIPS. FOLLOWING THE ABOVE, 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 ABOVE WAS RECEIVED, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER IN ORDER TO TEST WITH A NEW STRIPS CARTRIDGE AND CONTROL SOLUTION, HOWEVER THE USER INFORMED DARIO'S REPRESENTATIVE THAT HE WAS UNABLE TO PERFORM THE CONTROL SOLUTION TEST AT THAT TIME. AT A LATER DATE, ANOTHER ATTEMPT WAS MADE IN ORDER TO FOLLOW UP WITH THE USER, HOWEVER THERE WAS NO RESPONSE. 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 DECEMBER 4TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING THE FOLLOWING INCONSISTENT FASTING BG READINGS FROM HIS DARIO METER WHEN COMPARED TO HIS NON-DARIO METER: DARIO NON-DARIO 160 121 111 150 100 123 149 114 134 122 93 128 153 134 183 155 133 111 321 143 96 117.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821367 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD. 1021-06 2403041 00850065006758

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other