Description of Event or Problem · 1
ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY LOW COMPARED TO 2 OTHER METERS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS WELL AS ADDITIONAL INFORMATION. THE PATIENT REPORTED THE ALLEGED ISSUE OCCURRED ON (B)(6) 2012. THE PATIENT ALLEGED OBTAINING READINGS OF '300 AND 500MG/DL' ON THE LFS METER COMPARED TO '600+MG/DL' ON AN ACCU-CHEK AND BAYER METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% OR <=30MG/DL. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HER DIABETES. THE PATIENT REPORTED IMMEDIATELY AFTER THE ISSUE OCCURRED, SHE HAD LESS TO EAT OR DRINK THAN USUAL. THE PATIENT REPORTED DURING (B)(6) 2013, SHE WAS TREATED BY EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT REPORTED A READING OF '600+MG/DL' WAS OBTAINED ON THE EMS METER. THE PATIENT REPORTED SHE WAS TREATED WITH IV FLUIDS DURING (B)(6) 2012, (B)(6) 2013. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT. THE CCA NOTED THAT THE PATIENT'S TEST STRIPS AND TEST STRIPS VIAL WERE IN GOOD CONDITION. THE PATIENT WAS FOUND TO BE USING THE CORRECT TESTING STEPS AND AN APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, A SEVERELY HIGH READING WAS OBTAINED ON AN EMS METER AND SHE WAS TREATED BY EMS FOR A COMPLICATION OF DIABETES.