BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 19702414 · Received July 9, 2024

    Report

    Report Number
    3010606081-2024-00042
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 10, 2024
    Report Date
    June 10, 2024
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    UDI-DI
    00850065006253
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER WAS STORING THE STRIP CARTRIDGES 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." 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 147 MG/DL (RANGE 109-157 MG/DL). CONTROL SOLUTION LEVEL 2 TEST RESULTS WAS 232 MG/DL (RANGE 182-261 MG/DL). THE USER WAS INSTRUCTED TO TEST HIS BG LEVEL WITH THE NEW CARTRIDGE OF STRIPS, WHICH HE DID, AND RECEIVED A BG READING OF 155 MG/DL, WHICH THE USER STATED WAS TWO HOURS AFTER EATING, AND THEREFORE WAS NOT CERTAIN IF THIS BG READING WAS IN RANGE FOR HIM. DARIO'S REPRESENTATIVE RECOMMENDED FOR THE USER TO EMAIL DARIO HIS FASTING BG READINGS IN ORDER TO CONFIRM THAT HIS READINGS ARE WITHIN RANGE. THE USER EMAILED DARIO ON THE 24TH OF JUNE AND REPORTED THAT HE RECEIVED BG READINGS OF 95 MG/DL AND 89 MG/DL FOR THE PAST TWO DAYS, WHICH HE STATED WAS IN RANGE FOR HIM. SINCE THE USER'S BG READING ISSUE WAS RESOLVED WITH NEW STRIPS, THEREFORE, IT CAN BE DETERMINED THAT THERE WAS MISUSE OF THE STRIPS. THIS COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 0

    ON JUNE 10TH, 2024, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A BG READING OF 158 MG/DL FROM HIS DARIO METER. DUE TO THIS BG READING, THE USER OPENED A NEW CARTRIDGE OF STRIPS, WHERE HE TESTED AND RECEIVED A BG READING OF 89 MG/DL, WHICH THE USER STATED IS WITHIN HIS NORMAL FASTING RANGE OF 80 MG/DL TO 100 MG/DL. THE USER ALSO REPORTED THAT HE RECEIVED BG READINGS OF 79 MG/DL ON APRIL 28TH, 64 MG/DL ON MAY 12TH, AND 52 MG/DL ON MAY 26TH, WITHOUT EXPERIENCING ANY HYPOGLYCEMIC SYMPTOMS. DUE TO THESE LOW BG READINGS, THE USER DISCARDED THREE STRIP CARTRIDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268380 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD. 2107081 00850065006253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other