Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE PATIENT ALLEGING THE PATIENT¿S ONETOUCH ULTRA2 METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO HER FEELINGS OR NORMAL RESULTS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE PATIENT OR REPORTER FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED, THE ALLEGED ISSUE FIRST OCCURRED ¿A FEW WEEKS¿ PRIOR TO CONTACTING LFS. THE REPORTER STATED OBTAINING READINGS OF ¿276MG/DL.¿ THE REPORTER STATED, THE PATIENT USES A COMBINATION OF MEDICATIONS INCLUDING METFORMIN, 50MG IN THE MORNING AND LANTUS 12 UNITS IN THE EVENING. THE REPORTER STATED, THE PATIENT DID NOT MAKE ANY CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE REPORTER STATED, THE PATIENT DID NOT DEVELOP ANY SYMPTOMS ON THE DAY OF THE ALLEGED ISSUE. THE REPORTER STATED ON (B)(6) 2013 IN THE AFTERNOON, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER) AND WAS GIVEN SOMETHING TO EAT OR DRINK AS TREATMENT. THE REPORTER WAS UNABLE TO STATE WHAT READINGS WERE OBTAINED AT THE HOSPITAL. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE TEST STRIPS WERE IN GOOD CONDITION. HOWEVER WHEN A CONTROL SOLUTION TEST WAS RUN, THE RESULT WAS WITHIN THE RECOMMENDED RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUE, THE PATIENT REPORTED TREATMENT FROM A HEALTHCARE PROFESSIONAL IN THE ER.