Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A ONETOUCH ULTRAMINI METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO HER FEELINGS OR NORMAL RESULTS, COMPARED TO ANOTHER OT ULTRA2 METER AS WELL AS AN EMS METER.. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED DURING THE WEEK PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING READINGS OF ¿233, 104, 116 AND 500MG/DL¿ IT IS UNCLEAR HOW MUCH TIME PASSED IN BETWEEN THE READINGS. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HER DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. HOWEVER THE PATIENT REPORTED SIMULTANEOUSLY DEVELOPING SYMPTOMS OF ¿DIZZINESS, NAUSEA AND FATIGUE.¿ THE PATIENT REPORTED ON (B)(6) 2013 THE PATIENT WAS TREATED BY EMERGENCY MEDICAL SERVICES (EMS) WITH IV FLUIDS AND A READING OF ¿303MG/DL¿ WAS OBTAINED. THE PATIENT REPORTED A READING OF ¿346MG/DL¿ WAS OBTAINED BY EMS 1 WEEK PRIOR TO CONTACTING LFS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE SUBJECT TEST STRIPS AND CONTROL SOLUTION WERE RETURNED TO LFS PRODUCT ANALYSIS AND WERE NOT EVALUATED SINCE THE TEST STRIPS AND CONTROL SOLUTION WERE EXPIRED AT THE TIME OF THE ALLEGED COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED INACCURATE READINGS, THE PATIENT REQUIRED TREATMENT FROM EMS AFTER THE ALLEGED ISSUE OCCURRED, AND SEVERELY HIGH BLOOD GLUCOSE READINGS WERE OBTAINED.