BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 19824649 · Received July 25, 2024

    Report

    Report Number
    3010606081-2024-00046
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 25, 2024
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    UDI-DI
    00850065006154
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE USER WERE MADE, HOWEVER DARIO WAS UNABLE TO REACH THE USER IN ORDER TO TROUBLESHOOT. IN ONE OF THE USER'S EMAILS, IT WAS DETERMINED THAT HE WAS TRANSFERRING NEW DARIO STRIPS INTO THE OLD DARIO STRIPS CARTRIDGE. DARIO'S USER GUIDE STATES IN THE SECTION STORAGE AND HANDLING: "DO NOT TRANSFER TEST STRIPS FROM ONE CARTRIDGE TO ANOTHER". ONE ADDITIONAL ATTEMPT WAS MADE TO REACH THE USER, HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THE HIGH BG READINGS MAY HAVE BEEN DUE TO MISUSE OF THE STRIPS. THERE IS NOT ENOUGH INFORMATION REGARDING THE METER AND OLD STRIPS AVAILABLE TO FURTHER INVESTIGATE THIS CASE. THEREFORE, NO RESOLUTION IS AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER, WHO HAS BEEN USING THE DARIO METER FOR SEVERAL YEARS, REPORTED THAT UP TO JUNE 25TH, HIS DARIO METER WORKED WITH NO ISSUE. THE USER REPORTED THAT AFTER TESTING THREE TIMES WITH THREE DIFFERENT STRIPS, HE RECEIVED BG READINGS THAT WERE SO HIGH, THAT HE RECEIVED "HIGH" MESSAGES, RATHER THAN NUMERICAL BG READINGS. LATER THAT DAY, THE USER REPORTED TWO ADDITIONAL BG TESTS THAT RESULTED IN A "HIGH" MESSAGE. THE USER MENTIONED THAT HE HAD EATEN SOME SUGARY FOOD PRIOR TO RECEIVING THE HIGH READINGS. ON JULY 9TH, THE USER EMAILED DARIO AND REPORTED THAT AFTER TESTING HIS BG LEVEL SEVEN TIMES WITHIN A FEW MINUTES, HE RECEIVED INACCURATE RESULTS WITH HIS DARIO METER WHEN COMPARED TO HIS NON-DARIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366976 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD. NA 00850065006154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other