Description of Event or Problem · 1
ON (B)(6) 2021, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENTS ONETOUCH ULTRA MINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MSS AFTER FOLLOW-UP WITH CUSTOMER CARE. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2021 AT 11 PM. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE RESULTS OF 181, 353, 261 AND 211 MG/DL ON THE SUBJECT METER COMPARED TO 143, 135, 170, 160 AND 110 MG/DL ON A TRUE METRIX METER WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT STATES THAT SHE USUALLY MANAGES HER DIABETES WITH NOVOLIN INSULIN (8 UNITS IN THE MORNING AND 10 UNITS AT NIGHT). THE PATIENT DENIED TAKING ANY ACTION WITH REGARDS TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE REPORTED ISSUE. SHE CLAIMED THAT SHE ADMINISTERED HER USUAL DOSE OF INSULIN BEFORE BED AND WENT TO SLEEP. A COUPLE OF HOURS LATER, THE PATIENT WOKE AT 2 AM ON (B)(6) 2021, WITH SYMPTOMS OF SWEATING, GIBBERING, DIZZY AND BLURRY VISION . THE PATIENT DENIED RECEIVING ANY TREATMENT FOR THE REPORTED SYMPTOMS. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES. THE STRIPS HAD NOT BEEN OPEN LONGER THAN THE DISCARD DATE, HAD NOT EXPIRED, AND HAD BEEN STORED CORRECTLY. THE PATIENT HAD FOLLOWED THE CORRECT TESTING PROCESS. THE CCA WALKED THE REPORTER THROUGH A RETEST AND THE CONTROL SOLUTION TEST WAS NOT IN RANGE. 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 WHILE USING THE PRODUCT. THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.