Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER WAS DISPLAYING INACCURATE RESULTS WHEN COMPARED TO THE SAME METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED ON (B)(6) 2013, AT 6AM, SHE OBTAINED READINGS OF ¿249 AND 241MG/DL¿ ON THE LFS METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% OR <=20MG/DL WHEN OBTAINED WITHIN 20 MINUTES. THE PATIENT REPORTED USING ORAL MEDICATIONS WITH DIET AND EXERCISE TO MANAGE HER DIABETES. THE PATIENT REPORTED TAKING HER USUAL METFORMIN 1000MG TWICE A DAY AND GLIPIZIDE 2.5MG ONCE A DAY ON (B)(6) 2013, AT 6AM. THE PATIENT REPORTED IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿WARM AND SHAKY.¿ THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION IN RESPONSE TO HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT DURING THE TIME OF TESTING AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMED DUE TO THE ALLEGED ISSUE SHE TOOK HER USUAL DOSE OF MEDICATION AND SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.