Description of Event or Problem · 1
ON (B)(6) 2013 THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING HER HUSBAND'S ONETOUCH VERIOIQ METER WAS DISPLAYING INACCURATELY HIGH RESULTS COMPARED TO A DOCTOR'S METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2013 BETWEEN 3 AND 4PM, THE REPORTER STATED THE PATIENT OBTAINED A READING OF "111MG/DL" ON THE LFS METER COMPARED TO "70MG/DL" ON A DOCTOR'S METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% OR <=30MG/DL OBTAINED WITHIN 30 MINUTES OF ONE ANOTHER. THE REPORTER STATED THE PATIENT USES ORAL MEDICATIONS WITH DIET AND EXERCISE TO MANAGE HIS DIABETES. THE REPORTER WAS UNABLE OR UNWILLING TO REPORT IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE. THE REPORTER STATED ON (B)(6) 2013 3-4 MINUTES AFTER THE ISSUE FIRST OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF "SWEATINESS, FELL AND CRACKED HEAD OPEN." THE REPORTER STATED THE PATIENT WAS SEEN BY EMERGENCY MEDICAL SERVICES (EMS), AND A READING OF "110MG/DL" WAS OBTAINED. THE REPORTER STATED ON (B)(6) 2013 AT 5:36AM, THE PATIENT WAS GIVEN IV GLUCOSE IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER STATED THE PATIENT WAS DISCHARGED ON (B)(6) 2013 AT 2:30AM. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE CCA CONFIRMED THE PATIENT WAS USING THE CORRECT TEST STRIPS AND THAT THEY WERE IN GOOD CONDITION. IN ADDITION THE CCA NOTED THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES. WHEN A CONTROL SOLUTION TEST IS RUN, THE RESULT WAS WITHIN THE RECOMMENDED RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE REPORTER CLAIMED, DUE TO THE ALLEGED ISSUE HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED TREATMENT FROM EMS.