BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 23301955 · Received October 15, 2025

    Report

    Report Number
    3010606081-2025-00085
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 15, 2025
    Manufacturer
    LABSTYLE INNOVATIONS LTD
    Product Code
    NBW
    UDI-DI
    00850065006253
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER 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". A REPLACEMENT OF DARIO'S STRIPS WAS SENT TO THE USER. AFTER THE ABOVE WAS RECEIVED, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER, WHO STATED THAT SHE IS STILL RECEIVING INCONSISTENT READINGS AND REPORTED RECEIVING A READING OF 365 MG/DL FOLLOWED BY A SECOND READING OF 270 MG/DL USING HER REPLACEMENT OF DARIO'S STRIPS AND METER. DUE TO THE 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 WAS RECEIVED, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER WHO REPORTED THAT SHE RECEIVED A BG READING OF 404 MG/DL FOLLOWED BY A READING OF 289 MG/DL. THE USER THEN REQUESTED A FOLLOW UP CALL LATER THAT DAY FROM DARIO'S REPRESENTATIVE IN ORDER TO PERFORM A CONTROL SOLUTION TEST. DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER LATER THAT DAY AND 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 147 MG/DL (RANGE 110-159 MG/DL) CONTROL SOLUTION LEVEL 2 TEST RESULTS WAS 234 MG/DL (RANGE 192-277 MG/DL) DURING THIS TROUBLESHOOTING, IT WAS ALSO DETERMINED THAT THE USER WAS STORING HER CARTRIDGE OF STRIPS IN THE KITCHEN. DARIO'S USER GUIDE STATES IN THE SECTION OF GENERAL PRECAUTIONS: "DO NOT STORE THE METER OR TEST STRIPS IN AN AREA WHERE THE HUMIDITY IS OUTSIDE OF THE RANGE 10-90%, SUCH AS A BATHROOM OR KITCHEN." THE USER REPORTED THAT SHE PERFORMS THREE BG TESTS AND USES THE MIDDLE TEST RESULT IN ORDER TO DETERMINE HOW MUCH INSULIN TO ADMINISTER. THE USER ALSO STATED THAT THESE INCONSISTENT BG READINGS ALSO OCCUR WITH HER NON-DARIO METERS THAT SHE HAS, INCLUDING HER CGM DEVICE. ON (B)(6), AN ADDITIONAL ATTEMPT TO FOLLOW UP WITH THE USER WAS MADE, HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. AS OF THIS DATE, THE RMA WAS NOT RECEIVED. IF THE RMA IS RECEIVED AT A LATER DATE, A FOLLOW UP REPORT WILL BE SUBMITTED. 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 (B)(6), DARIO'S REPRESENTATIVE CONTACTED THE USER IN ORDER TO FOLLOW UP REGARDING THE REPLACEMENT METER THAT THE USER RECENTLY RECEIVED. THE USER REPORTED A DIFFERENCE IN THE RANGE OF 15 MG/DL TO 20 MG/DL IN HER BG READINGS WHEN PERFORMING CONSECUTIVE TESTS WITH HER DARIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019537 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD 1021-04 2204214 00850065006253

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other