Description of Event or Problem · 1
ON (B)(6) JULY 2019, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA MINI METER WAS READING CONTROL SOLUTION INACCURATELY LOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2019, 4:00PM. THE PATIENT HAD OBTAINED AN ALLEGED CONTROL SOLUTION RESULT OF "119MG/DL" COMPARED TO THE ACCEPTABLE RANGE PRINTED ON THE TEST STRIP VIAL OF, 127 - 171MG/DL. THE PATIENT MANAGES HER DIABETES BY SELF-ADJUSTING INSULIN DOSES (NOVOLOG AND TOUJEO) AND REPORTED THAT SHE MADE NO CHANGE TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT DETAILED THAT ON (B)(6) 2019 ,12:15PM HE DEVELOPED THE SYMPTOMS OF "SHAKY, SWEATY AND BLURRED VISION". HE REPORTED THAT "RIGHT AFTER" HE SELF-TREATED BY DRINKING SOME ORANGE JUICE. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THE PATIENT CARRIED OUT THE CORRECT TESTING STEPS, USED THE CORRECT CONTROL SOLUTION AND CORRECT UNIT OF MEASURE WAS USED. THE CONTROL SOLUTION RESULT OBTAINED FELL OUTSIDE THE ACCEPTABLE RANGE ON THE TEST STRIP VIAL. THE TEST STRIPS WERE STORED CORRECTLY AND WITHIN THEIR EXPIRY DATE. THE CONTROL SOLUTION USED HAD NOT EXPIRED. THE TEST STRIP VIAL WAS NEITHER CRACKED NOR BROKEN. THE PATIENT'S PRODUCTS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS' CRITERIA FOR A SERIOUS INJURY ADVERSE EVENT AFTER OBTAINING AN ALLEGED INACCURATE CONTROL SOLUTION RESULT WITH THE SUBJECT METER AND CONTINUING WITH HER USUAL DIABETES MANAGEMENT ROUTINE.