Description of Event or Problem · 1
ON APRIL 27TH, THE USER'S DAUGHTER CONTACTED DARIO TO REPORT ELEVATED BLOOD GLUCOSE (BG) READINGS. PRIOR TO CONTACTING DARIO, THE USER'S DAUGHTER REPORTED THAT HER FATHER RECEIVED A READING OF APPROXIMATELY 260 MG/DL, WHICH IS 100 POINTS HIGHER THAN THE USER'S NORMAL BG LEVEL. DUE TO THE ABOVE, THE USER'S DAUGHTER REPORTED THAT THE USER'S DOCTOR INCREASED HIS MEDICATION BY 1 ADDITIONAL PILL A DAY. THE USER'S DAUGHTER REPORTED THAT DESPITE THE USER BEING ON THE INCREASED MEDICATION FOR APPROXIMATELY A WEEK, THE USER WAS STILL RECEIVING ELEVATED BG READINGS IN THE RANGE OF 250-270 MG/DL. DUE TO THE ABOVE, THE USER'S DOCTOR SUGGESTED TESTING THE OTHER FAMILY MEMBERS WHO ARE NOT DIABETIC IN ORDER TO COMPARE BG READINGS. THE RESULTS SHOWED THAT THE DARIO METER WAS READING ABOVE 200 MG/DL FOR THE OTHER FAMILY MEMBERS AS WELL. THE DOCTOR ALSO SUGGESTED THAT THE USER COME INTO THE OFFICE TO TEST HIS BG LEVELS. THE USER WENT TO HIS DOCTOR, WHERE HIS BG LEVEL WAS TESTED WITH THE DOCTOR'S METER AND READ 125 MG/DL. WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER HAD BEEN USING AN EXPIRED CARTRIDGE OF STRIPS. DARIO'S USER GUIDE STATES IN THE SECTION REGARDING "FACTORS THAT MAY LEAD TO INACCURATE RESULTS", THAT THE USE OF STRIPS AFTER THE EXPIRATION DATE MAY LEAD TO INACCURATE RESULTS. A REPLACEMENT OF DARIO'S STRIPS AND CONTROL SOLUTION WERE SENT TO THE USER TO FURTHER INVESTIGATE THIS ISSUE. MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE USER WERE MADE, IN ORDER TO CONFIRM THAT THE ISSUE IS RESOLVED WITH A NEW CARTRIDGE OF STRIPS, HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THE HIGH BG READINGS MAY HAVE BEEN DUE TO THE USE OF EXPIRED STRIPS. NO OTHER PRODUCT PROBLEM WAS REPORTED. NO RESOLUTION IS AVAILABLE.