BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 19737507 · Received July 14, 2024

    Report

    Report Number
    3010606081-2024-00044
    Event Type
    Malfunction
    Date Received
    July 14, 2024
    Date of Event
    June 14, 2024
    Report Date
    June 14, 2024
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    UDI-DI
    00850065006154
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING ON THE PHONE WITH DARIO'S REPRESENTATIVE, THE USER STATED THAT SHE LIVES IN HAWAII, AND THEREFORE THE STRIPS MAY HAVE BEEN EXPOSED TO HIGH TEMPERATURES AND HUMIDITY. DARIO'S USER GUIDE STATES IN THE SECTION OF GENERAL PRECAUTIONS: "BLOOD GLUCOSE TESTING WITH THE DARIO SYSTEM SHOULD ONLY BE DONE IN TEMPERATURES BETWEEN 50°F-95°F (10°C-35°C) AND RELATIVE HUMIDITY BETWEEN 15-85%. TEST RESULTS MAY NOT BE CORRECT IF THE ROOM TEMPERATURE AND/OR HUMIDITY ARE OUTSIDE THIS RANGE." 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 149 MG/DL (RANGE 109-157 MG/DL) CONTROL SOLUTION LEVEL 2 TEST RESULTS WAS 235 MG/DL (RANGE 182-261 MG/DL). THE USER REPORTED THAT SHE RECEIVED A BG READING OF 107 MG/DL WITH THE NEW CARTRIDGE OF STRIPS, WHICH SHE STATED WAS IN RANGE FOR HER. SINCE THE USER'S CONTROL SOLUTION READING ISSUE WAS RESOLVED WITH NEW STRIPS, IT CAN BE DETERMINED THAT THE HIGH CONTROL SOLUTION READINGS MAY HAVE BEEN DUE TO THE HIGH ENVIRONMENTAL TEMPERATURE AND HUMIDITY. THERE IS NOT ENOUGH INFORMATION REGARDING THE 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 AND OUT OF RANGE READINGS WHEN PERFORMING THE CONTROL SOLUTION TESTS. THE USER, WHO HAS TWO DARIO METERS, REPORTED RECEIVING HIGH READINGS ON HER CONTROL SOLUTION TEST FOR BOTH DARIO METERS. THE USER REPORTED AN AVERAGE READING OF 168 MG/DL ON CONTROL SOLUTION LEVEL ONE, WITH A RANGE OF 90 MG/DL TO 140 MG/DL, AND ON CONTROL SOLUTION LEVEL TWO, THE USER RECEIVED A READING OF 618 MG/DL, WHICH THE USER STATED WAS HIGHER THAN THE RANGE OF CONTROL SOLUTION LEVEL TWO. DUE TO THE ABOVE, THE USER OPENED A NEW CARTRIDGE OF STRIPS, HOWEVER SHE REPORTED THAT SHE STILL RECEIVED READINGS THAT WERE TOO HIGH, ALTHOUGH LESS THAN THE PREVIOUS READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392154 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD. 2109031 AND 1805191 00850065006154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other