Description of Event or Problem · 1
ON (B)(6), THE USER CONTACTED DARIO TO REPORT THAT FOR THE PAST SEVERAL WEEKS HE WAS RECEIVING HIGH BLOOD GLUCOSE (BG) READINGS. DUE TO THESE HIGH READINGS, THE USER BEGAN TO INCREASE HIS MEDICATION. THE USER REPORTED THAT THERE WERE 2 INCIDENTS IN THE PAST COUPLE OF WEEKS WHERE HE OVER-MEDICATED DUE TO HIGH BG READINGS, CAUSING HIS BG LEVELS TO DECREASE TOO LOW. THE USER REPORTED THAT HE DID NOT GO TO THE HOSPITAL OR TALK TO HIS DOCTOR DURING THESE INCIDENTS. THE USER REPORTED THAT HE DRANK SOME SODA AND THEN HIS BG LEVELS STABILIZED. WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, THE USER REPORTED THAT HAD BEEN MEASURING HIS BG LEVELS IN THE EVENING AND MEDICATING AFTERWARDS. THE USER REPORTED BEING SURPRISED WHEN HE FOUND HIS BG LEVELS TO BE HIGH IN THE MORNING. THE USER REPORTED RECEIVING A READING OF 177 MG/DL ON HIS DARIO METER COMPARED TO A READING OF 127 MG/DL ON HIS BACK-UP NON-DARIO METER. THE USER REPORTED THAT THIS WAS WHEN HE REALIZED THAT HE HAD BEEN USING A CARTRIDGE OF STRIPS THAT EXPIRED IN FEBRUARY 2021. 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 METER, CARTRIDGE OF STRIPS, AND CONTROL SOLUTION WERE SENT TO THE USER TO FURTHER INVESTIGATE THIS ISSUE. AFTER THE ABOVE WAS RECEIVED, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER AND HE REPORTED THAT THE CONTROL SOLUTION TEST WITH THE NEW CARTRIDGE OF STRIPS WERE READING WITHIN RANGE. THE USER DID NOT PROVIDE US WITH THE TEST RESULTS. THEREFORE, IT CAN BE DETERMINED THAT THERE WAS MISUSE OF THE STRIPS (OFF-LABEL USE). THIS COMPLAINT IS NOT CONFIRMED.