BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 19086116 · Received April 11, 2024

    Report

    Report Number
    3010606081-2024-00022
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 12, 2024
    Report Date
    March 12, 2024
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING ON THE PHONE WITH DARIO'S REPRESENTATIVE, THE USER REPORTED THAT SHE WAS USING A CARTRIDGE OF STRIPS THAT HAD EXPIRED IN JANUARY 2023. 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 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, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER. 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 RESULT WAS 115 MG/DL (RANGE 105-151 MG/DL) CONTROL SOLUTION LEVEL 2 TEST RESULT WAS 234 MG/DL (RANGE 182-261 MG/DL). FOLLOWING THE ABOVE, THE USER TESTED HER BG READINGS WITH THE NEW CARTRIDGE OF STRIPS. SHE RECEIVED BG READINGS OF 181 MG/DL AND 186 MG/DL. IMMEDIATELY THEREAFTER, SHE TESTED AGAIN AND RECEIVED BG READINGS OF 124 MG/DL AND 224 MG/DL. DUE TO THE DIFFERENCE IN READINGS ABOVE, A REPLACEMENT OF DARIO'S METER, WAS SENT TO THE USER TOGETHER WITH A RETURN MATERIAL AUTHORIZATION (RMA) PACKAGE, TO FURTHER INVESTIGATE THIS ISSUE. AFTER THE REPLACEMENT OF THE NEW DARIO METER WAS RECEIVED BY THE USER, A DARIO REPRESENTATIVE FOLLOWED UP WITH THE USER WHO STATED THAT HER READINGS ARE NOW IN RANGE FOR HER. THE RMA PACKAGE WAS RECEIVED FOR INVESTIGATION ON APRIL 2ND, 2024. THE METER WAS TESTED AND WAS READING WITHIN RANGE. THEREFORE, IT WAS DETERMINED THAT THIS COMPLAINT IS NOT DUE TO A METER ISSUE. THE HIGH BG READINGS MAY HAVE BEEN DUE TO MISUSE OF THE STRIPS OR IMPROPER TESTING TECHNIQUE. THERE IS NOT ENOUGH INFORMATION REGARDING THE DARIO STRIPS TO INVESTIGATE. NO RESOLUTION IS AVAILABLE.

    Description of Event or Problem · 0

    ON MARCH 12TH, 2024, THE USER CONTACTED DARIO TO REPORT INCONSISTENT AND HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING CONSECUTIVE INCONSISTENT AND HIGH BG READINGS OF 235 MG/DL, 239 MG/DL AND 257 MG/DL FROM HER DARIO METER WITHIN A FEW MINUTES OF EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333895 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD. 2104301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other