D
Patient 1
ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH VERIOIQ METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN SOMETIME BEFORE (B)(6) 2019. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH READINGS IN THE MORNING OF AROUND ?185 AND 189 MG/DL? WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (1 PILL OF GLIPIZIDE TWICE DAILY). THE PATIENT CLAIMED THAT SOMETIME BEFORE (B)(6) 2019, HER DOCTOR INCREASED HER DOSE OF GLIPIZIDE TO 2.5 PILLS TWICE DAILY AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT SINCE THE INCREASE IN DOSE, SHE WOULD WAKE UP FEELING ?SHAKY.? THE PATIENT INDICATED THAT WHEN SHE WAS INVOLVED IN A CAR ACCIDENT IN LATE (B)(6) 2019, SHE BECAME OF THE ALLEGED ISSUE AS HER HEMOGLOBIN A1C WAS MEASURED AT 6.5 % WHICH SHE CLAIMED WAS INCONSISTENT WITH HER BLOOD GLUCOSE READINGS. THE PATIENT CLAIMED THAT ON (B)(6) 2019, HER DOCTOR CHANGED HER DOSE OF GLIPIZIDE BACK TO 1 PILL TWICE DAILY. NO OTHER DEVICE WAS USED FOR TESTING AND NO ADDITIONAL TREATMENT WAS REPORTED. AT THE TIME OF TROUBLESHOOTING, THE CSA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE PATIENT'S HCP INCREASED HER DOSE OF GLIPIZIDE BASED ON ALLEGED INACCURATE HIGH READINGS OBTAINED ON THE SUBJECT METER.