Description of Event or Problem · 1
ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH VERIOIQ METER WAS READING INACCURATELY COMPARED TO THE SAME METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED ON (B)(6) 2012 AT 8:23AM, HE OBTAINED READINGS OF "161 AND 96MG/DL" ON HIS LFS METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE READINGS EXCEEDS THE EXPECTED RESULT OF <=20% OR <=15MG/DL OBTAINED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT REPORTED USING ORAL MEDICATIONS WITH DIET AND EXERCISE TO MANAGE HIS DIABETES. THE PATIENT REPORTED ON (B)(6) 2012 AT 10AM, HE SELF TREATED WITH GLYBURIDE 5MG. THE PATIENT REPORTED ON (B)(6) 2012 HE INCREASED HIS USUAL DOSE OF MEDICATION INCLUDING 5 MG OF GLYBURIDE AT 10AM AND AT 5PM. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS ON THE DAY OF THE ALLEGED ISSUES. THE PATIENT DENIED TESTING ON ANOTHER DEVICE. DURING THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE PATIENT WAS USING THE SAME APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. THE CCA NOTED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT DURING THE TIME OF TESTING. THE CCA DOCUMENTED THAT THE PATIENT'S TESTING PROCESS WAS CORRECT AND HIS TEST STRIPS AND TEST STRIP VIAL WERE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTIVE THAT AN ACUTE COMPLICATION OF DIABETES OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT PERFORMED A METER VS. SAME METER COMPARISON WHERE THE CALCULATED DIFFERENCE OF THE RESULTS MEETS LFS' CRITERIA FOR PRECISION REPORTING.