BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 24601691 · Received March 15, 2026

    Report

    Report Number
    3010606081-2026-00018
    Event Type
    Malfunction
    Date Received
    March 15, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 15, 2026
    Manufacturer
    LABSTYLE INNOVATIONS LTD
    Product Code
    NBW
    UDI-DI
    00850065006390
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING ON THE PHONE WITH DARIO'S REPRESENTATIVE, THE USER REPORTED RECEIVED THE FOLLOWING BG READINGS ON THE FOLLOWING DATES: USING THE DARIO METER: (B)(6) 2026 - 76 MG/DL, (B)(6) 2026 - 88 MG/DL, (B)(6) 2026 - 90 MG/DL. USING THE USER'S NON-DARIO METER: (B)(6) 2026 - 122 MG/DL, (B)(6) 2026 - 121 MG/DL, (B)(6) 2026 - 115 MG/DL. FOLLOWING THE INFORMATION THAT THE USER PROVIDED ABOVE, THE USER OPENED A NEW CARTRIDGE OF STRIPS, TESTED HIS BG AND RECEIVED FROM HIS DARIO METER A READING OF 109 MG/DL COMPARED TO A BG READING OF 136 MG/DL FROM HIS NON-DARIO METER. 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 RESULTS WAS 113 MG/DL (RANGE 104-149 MG/DL). CONTROL SOLUTION LEVEL 2 TEST RESULTS WAS 194 MG/DL (RANGE 187-269 MG/DL). DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER ONE WEEK LATER. THE USER REPORTED THAT HIS BG READINGS ARE NOW IN THE MID 90 MG/DL RANGE, WHICH IS IN NORMAL RANGE FOR HIM. THE USER'S ISSUE WAS RESOLVED WITH THE NEW STRIPS. THERE IS NOT ENOUGH INFORMATION REGARDING THE OLD DARIO STRIPS TO INVESTIGATE.

    Description of Event or Problem · 0

    ON FEBRUARY 17TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS FROM HIS DARIO METER THAT WERE 25 MG/DL TO 30 MG/DL LOWER THAN HIS PREVIOUS BG READINGS. THE USER ALSO REPORTED THAT HE RECENTLY HAD LAB WORK DONE, WHERE HE RECEIVED A BG READING OF 109 MG/DL AND AN A1C OF 5.8%. THE USER STATED THAT ON THAT SAME DAY OF RECEIVING THE BLOOD WORK, HE RECEIVED FROM HIS DARIO METER A BG READING OF 82 MG/DL. DUE TO THE ABOVE, THE USER STATED THAT HIS DOCTOR ADVISED HIM TO FOLLOW UP ON HIS BG READINGS WITH THE DARIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662699 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD 1021-06 2203021 00850065006390

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other