Description of Event or Problem · 1
ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER (TRUE METRIX). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN ON (B)(6) 2020. THE PATIENT REPORTED OBTAINING READINGS OF "120, 287, 139, 153, 221 AND 135 MG/DL" WITH THE SUBJECT METER AND "102, 245, 83, 129, 197 AND 108 MG/DL" RESPECTIVELY ON THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN TAKEN 4 TIMES A DAY AND THAT AS A RESULT OF THE ALLEGED ISSUE, SHE CUT OUT SNACKS FROM HER DIET. THE PATIENT REPORTED THAT ON (B)(6) 2020 AT AROUND 4:00 PM, SHE OBTAINED A RESULT OF "84 MG/DL" WITH THE SUBJECT METER AND STARTED "SHAKING." THE PATIENT INDICATED THAT SHE NORMALLY BECOMES SYMPTOMATIC FOR HYPOGLYCEMIA WHEN HER BLOOD GLUCOSE FALLS BELOW 60 MG/DL. THE PATIENT CLAIMED SHE TOOK A DRINK WITH SUGAR AS SELF-TREATMENT FOR THE SYMPTOM, RESTED AND FELT BETTER AFTER. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING AND THAT THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRECT AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE CCA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCT WAS 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 ALLEGED INACCURACY ISSUE BEGAN. THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.