Description of Event or Problem · 1
ON (B)(6) 2019, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE READINGS. SHE INDICATED THAT IN THE MORNING PRIOR TO CONTACTING DARIO, SHE MEASURED LOW BLOOD GLUCOSE (BG) LEVELS WITH READINGS OF BELOW 20 MG/DL. THE USER REPORTED THAT SHE WAS COLD, SWEATY, SHAKY AND DROWSY. SHE TOOK A GLUCOSE GEL WHEN SHE HAD THE LOW READINGS, AND FIVE MINUTES LATER SHE MEASURED HER BG WITH A READING OF 78 MG/DL. A COUPLE OF HOURS LATER, SHE TOOK A SECOND GLUCOSE GEL, AND TEN MINUTES LATER MEASURED HER BG WITH A READING OF 256 MG/DL. TWENTY MINUTES AFTER THAT SHE MEASURED HER BG WITH A READING OF 93 MG/DL. AN HOUR LATER, SHE MEASURED HER BG WITH A READING OF 70 MG/DL. SHE HAD LUNCH AND AFTER TWENTY MINUTES SHE CALLED DARIO, WHILE ON THE CALL, SHE WAS INSTRUCTED TO OPEN A NEW CARTRIDGE OF STRIPS AND TEST HER BLOOD GLUCOSE, THE READING RESULT WAS 135 MG/DL (AFTER LUNCH). SHE WAS THEN INSTRUCTED TO TEST AGAIN WITH THE ORIGINAL CARTRIDGE OF STRIPS, AND SHE MEASURED BG WITH A READING OF 137 MG/DL. THE USER REPORTED THAT THE STRIPS WERE HANDLED AS PER LABELING. HOWEVER, SHE STARTED TAKING NEW MEDICATION WITH HIGHER FREQUENCY (WITH COMPARISON TO THE OLD MEDICATION), TWICE PER DAY INSTEAD OF ONCE A DAY. IN ADDITION, THE LOW READINGS OF BELOW 20 MG/DL THAT THE USER REPORTED, ARE NOT POSSIBLE, AS THERE IS NO NUMERICAL RESULT OF BLOOD GLUCOSE READINGS UNDER 20 MG/DL; AS PER LABELING: 'IF YOUR TEST RESULT IS LOWER THAN 20 MG/DL (1.1 MMOL/L)', THE DEVICE DISPLAYS "LOW! MEASURE WITH A NEW STRIP, IF RECURS CONTACT YOUR PHYSICIAN IMMEDIATELY". DARIO REPRESENTATIVE ADVISED THE USER TO CONTACT HER DOCTOR, SHE STATED THAT SHE HAD ALREADY DONE SO. THE CUSTOMER WAS SENT A REPLACEMENT DARIO METER, STRIPS, AND CONTROL SOLUTION. THE ORIGINAL METER WAS SENT BACK FOR INVESTIGATION. THE RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED. THE FAILURE MODE WAS NOT CONFIRMED.