Description of Event or Problem · 1
ON APRIL 27TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A READING OF 325 MG/DL ON HER DARIO METER COMPARED TO A READING OF 225 MG/DL ON HER NON-DARIO METER. THE USER REPORTED THAT THERE WERE SEVERAL INCIDENTS IN THE PAST COUPLE OF MONTHS WHERE SHE OVER-MEDICATED DUE TO HIGH BG READINGS, CAUSING HER BG LEVELS TO DECREASE TOO LOW. DURING ONE OF THESE INCIDENTS, THE USER REPORTED THAT HER BG LEVEL WAS SO LOW THAT SHE FELL TO THE FLOOR. HER HUSBAND HELPED HER UP, AND TESTED HER BG LEVEL, WHICH READ 46 MG/DL. THE USER REPORTED THAT SHE ATE EVERY HALF AN HOUR, FOR AN HOUR AND A HALF, IN ORDER TO BRING HER BG LEVEL BACK UP TO ABOVE 90 MG/DL, AND THEN SHE FELT THAT HER BG LEVEL WAS STABLE ENOUGH TO GO BACK TO SLEEP. A REPLACEMENT OF DARIO'S CONTROL SOLUTION WAS SENT TO THE USER TO FURTHER INVESTIGATE THIS ISSUE. AFTER THE ABOVE WAS RECEIVED, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER AND SHE REPORTED THAT THE CONTROL SOLUTION TEST WAS READING WITHIN RANGE. IN ADDITION, THE USER PERFORMED COMPARISON BG TESTING BETWEEN HER DARIO METER AND HER NON-DARIO METER FOR 8 DAYS, AND REPORTED THAT SOME OF THE BG READINGS STILL HAD A DIFFERENCE BETWEEN THE TWO METERS. THE USER'S ENDOCRINOLOGIST RECOMMENDED HER TO DISCONTINUE THE USE OF THE DARIO AND TO SWITCH TO A CGM SYSTEM. FOLLOW UP WITH THE USER WAS ATTEMPTED, IN ORDER TO FURTHER INVESTIGATE THE ISSUE, HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE.THERE IS NOT ENOUGH INFORMATION REGARDING THE DARIO STRIPS AND METER TO INVESTIGATE. NO RESOLUTION IS AVAILABLE.