Description of Event or Problem · 1
ON JULY 6, 2020, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THEIR ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT 12 A.M., ON (B)(6) 2020. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿177, 151, 172, 92, 157 AND 188 MG/DL¿ WITH THE SUBJECT DEVICE WHICH SHE FELT WERE INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF INSULIN (15 UNITS IN THE MORNING AND 15 UNITS IN THE EVENING, UNSPECIFIED TYPE) AND ORAL MEDICATION (1 PILL OF METFORMIN IN THE AFTERNOONS, SPECIFIC DOSE NOT REPORTED) AND SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURACY ISSUE. THE PATIENT REPORTED TO THE CCA THAT ON (B)(6) 2020, AFTER EATING DINNER, SHE PERFORMED A BLOOD GLUCOSE TEST WITH THE SUBJECT DEVICE; REPORTEDLY OBTAINED A RESULT OF ¿51 MG/DL¿ AND FELT ¿DIZZY, CONFUSED¿ AND WAS ¿SWEATING¿. THE PATIENT STATED THAT SHE SELF-TREATED BY EATING COOKIES AND DRINKING JUICE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME OF TESTING. THE CCA ALSO NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE AT THE TIME OF THE CALL TO TEST THE SUBJECT DEVICE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT WHILST USING THE SUBJECT DEVICE. ALTHOUGH THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿51 MG/DL¿ AT THE TIME OF THE EVENT WHICH IS CONSISTENT WITH THE SYMPTOMS THE PATIENT DEVELOPED, THE ALLEGED INACCURACY ISSUE COULD NOT BE RULED OUT AS A CAUSE AND/OR CONTRIBUTOR TO THE EVENT.