Description of Event or Problem · 0
ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT AROUND 8 A.M., ON (B)(6) 2024. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE RESULTS OF ¿147, 150, 139, 131 AND 125 MG/DL¿ WITH THE SUBJECT DEVICE WHICH THEY FELT WERE INACCURATELY HIGH COMPARED TO THEIR FEELING AND/OR NORMAL READINGS. THE PATIENT MANAGES THEIR DIABETES WITH NON-INSULIN INJECTIONS (OZEMPIC, UNSPECIFIED DOSE) AND DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT AN UNSPECIFIED TIME AFTER OBTAINING THE ALLEGED INACCURATELY HIGH BLOOD GLUCOSE READINGS, THEY DEVELOPED ¿SHAKINESS¿. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE DEVICE AT THE TIME OF TESTING. THE CCA ESTABLISHED THAT THE TEST STRIP VIAL WAS INTACT, THAT THE TEST STRIPS HAD BEEN STORED PROPERLY, WERE NOT OPEN BEYOND THEIR DISCARD DATE AND HAD NOT EXPIRED. THE CCA ALSO NOTED THAT AT THE TIME OF THE CALL, THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT SYSTEM. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION AFTER OBTAINING ALLEGED INACCURATELY HIGH BLOOD GLUCOSE READINGS ON THE SUBJECT DEVICE.