Description of Event or Problem · 1
ON (B)(6) 2018, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH IN COMPARISON TO FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6) 2018. HE REPORTED THAT HE OBTAINED ALLEGED INACCURATELY HIGH RESULTS OF ¿265, 253, 217, 274, 204, AND 215MG/DL¿ ON THE SUBJECT METER COMPARED TO FEELINGS/NORMAL RESULTS. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE THE POSSIBILITY OF INACCURACY. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION ¿TRULICITY ONCE A WEEK, 1 X GLIPIZIDE TWICE DAILY AND METFORMIN 2 X 500MG TWICE DAILY¿ DIET AND EXERCISE AND REPORTED THAT HE MADE NO CHANGE TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT STATED THAT ON (B)(6) 2018, 6:35PM HE DEVELOPED THE SYMPTOMS OF ¿FELT SHAKY¿. THE PATIENT REPORTED THAT SHE SELF-TREATED WITH FOOD AND OR/DRINK ¿BEEF STROGANOFF, PEAS AND WATERMELON AND FELT FINE¿. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. HOWEVER, THE TEST STRIPS HAD BEEN STORED INCORRECTLY ¿ THE TEST STRIP VIAL WAS LEFT OPEN. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.