Description of Event or Problem · 1
ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER READ INACCURATELY ERRATIC AND INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ONE WEEK PRIOR TO CONTACTING LFS. THE PATIENT CLAIMED OBTAINING INACCURATE HIGH BLOOD GLUCOSE READINGS OF "305, 343, 295, 294, 313, 345, 218, 127, 167, 192 AND 223 MG/DL" WITH THE SUBJECT METER. THE PATIENT ALSO CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "223, 192 AND 167 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (METFORMIN 750 MG DAILY) AND INSULIN (ADMELOG 16 UNITS BEFORE EACH MEAL; BASAGLAR 20 UNITS AT NIGHT). THE PATIENT CLAIMED SHE TOOK MORE INSULIN THAN NEEDED BASED ON THE ALLEGED INACCURATE RESULTS (AMOUNT NOT REPORTED) AND DEVELOPED SYMPTOMS OF FEELING "LIKE A ZOMBIE, SLEEPY AND LIGHTHEADED" BETWEEN (B)(6) 2020 AND (B)(6) 2020. THE PATIENT CLAIMED THAT WITHOUT TAKING INSULIN ON (B)(6) 2020, THE SYMPTOMS RESOLVED. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THAT THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA NOTED THAT 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 TAKING INSULIN BASED ON ALLEGED INACCURATE RESULTS OBTAINED WITH THE SUBJECT METER.