Description of Event or Problem · 1
ON SEPTEMBER 15TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER'S HUSBAND REPORTED THAT IN THE MORNING, PRIOR TO CONTACTING DARIO, HIS WIFE RECEIVED A BG READING OF OVER 300 MG/DL WITH HER DARIO METER. DUE TO THIS HIGH READING, THE USER'S HUSBAND REPORTED THAT HIS WIFE ADMINISTERED 35 UNITS OF INSULIN. SEVERAL HOURS LATER, AROUND LUNCH TIME, THE USER'S HUSBAND RE-TESTED HIS WIFE'S BG AND RECEIVED A READING OF 239 MG/DL. THE USER THEN ADMINISTERED ANOTHER 35 UNITS OF INSULIN. THE USER'S HUSBAND REPORTED THAT THEY WENT TO THE PAIN MANAGEMENT DOCTOR, WHERE THEY WERE TOLD THAT THEY ARE AWARE OF THE USER'S DIABETES, AND DID NOT RECEIVE ANY FURTHER MEDICAL ASSISTANCE OR TREATMENT. APPROXIMATELY AN HOUR PRIOR TO CONTACTING DARIO, THE USER'S HUSBAND TESTED HIS WIFE'S BG LEVEL ONCE AGAIN AND RECEIVED A READING OF 180 MG/DL. THE USER'S HUSBAND STATED THAT HIS WIFE HAS A CGM AND HADN'T USED THE DARIO METER FOR A WHILE. THE USER'S HUSBAND WAS UNSURE WHEN HIS WIFE OPENED THE STRIPS. DARIO'S REPRESENTATIVE UPDATED THE USER THAT THE STRIPS EXPIRE AFTER 30 DAYS. SINCE THE USER'S HUSBAND STATED THAT HIS WIFE WAS INCOHERENT AT THE TIME OF THIS CALL, DARIO'S REPRESENTATIVE ADVISED THE HUSBAND TO TAKE HIS WIFE TO THE DOCTOR AS SOON AS POSSIBLE. THE FOLLOWING DAY, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER'S HUSBAND WHO REPORTED THAT RIGHT AFTER THE CALL WITH DARIO HE WENT TO THE STORE AND BOUGHT A BACKUP METER IN ORDER TO RETEST HIS WIFE'S BG. THE USER WAS HAVING A LOW EVENT AND RECEIVED A READING OF 50 MG/DL WITH THE NON-DARIO METER. THE USER'S HUSBAND REPORTED THAT HE THEN SPOKE TO HIS WIFE'S ENDOCRINOLOGIST'S NURSE, WHO ADVISED THAT THE USER WILL ADMINISTER TWO GLUCOSE TABLETS AND DRINK ORANGE JUICE IN ORDER TO RAISE THE USER'S BG LEVEL. AFTER DOING THE ABOVE, THE USER'S HUSBAND REPORTED THAT HER BG READING IS 157 MG/DL, WHICH IS NORMAL FOR HIS WIFE, AND THAT SHE IS NOW FEELING MUCH BETTER. THE USER STATED THAT SHE TAKES 35 UNITS OF NOVOLOG WITH BREAKFAST AND LUNCH AND 50 UNITS OF NOVOLOG AT DINNER TIME. IN ADDITION, THE USER ALSO TAKES 96 UNITS OF LANTUS AT BEDTIME. ON WEDNESDAYS, THE USER STATED THAT SHE TAKES 5 UNITS OF TRULICITY. THE USER'S HUSBAND STATED THAT HIS WIFE HAS 3 METERS AND HAD TRANSFERRED STRIPS FROM THE OTHER TWO CARTRIDGES INTO THE USED CARTRIDGE. DARIO'S REPRESENTATIVE EDUCATED THE USER THAT TRANSFERRING STRIPS FROM ONE CARTRIDGE TO ANOTHER MAY CONTAMINATE THEM. DARIO'S USER GUIDE STATES IN THE SECTION "STORAGE AND HANDLING", " DO NOT TRANSFER TEST STRIPS FROM ONE CARTRIDGE TO ANOTHER." THE USER WAS SENT NEW TESTING SUPPLIES, HOWEVER, THE USER DID NOT CALL BACK TO REPORT ON HER BG TESTING RESULTS. THE HIGH BG READINGS MAY HAVE BEEN DUE TO THE MISUSE OF STRIPS. THERE IS NOT ENOUGH INFORMATION AVAILABLE TO FURTHER INVESTIGATE THIS CASE. THEREFORE, NO RESOLUTION IS AVAILABLE.