Description of Event or Problem · 1
ON (B)(6) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THEIR ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN IN (B)(6) 2014. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿220, 160 AND 170MG/DL¿ ON THE SUBJECT METER AND READINGS ¿40-50MG/DL¿ LOWER ON A ¿FREESTYLE¿ METER, OBTAINED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE PATIENT MANAGES THEIR DIABETES WITH AN INSULIN PUMP. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿SHAKY AND DIZZINESS¿ SOMETIME AFTER THE ALLEGED INACCURACY BEGAN. THE PATIENT REPORTED CONSUMING MORE FOOD/DRINK BUT THE PATIENT COULD NOT RECALL HOW MUCH TIME PASSED BETWEEN THESE EVENTS. AT THE TIME OF TROUBLESHOOTING THE CSR VERIFIED THAT THE UNIT OF MEASURE WAS SET CORRECTLY AND THAT THE TEST STRIPS WERE STORED CORRECTLY (PER OWNER¿S BOOKLET RECOMMENDATION). A CONTROL SOLUTION TEST PERFORMED AT THE TIME OF THE CALL FELL WITHIN THE ACCEPTED RANGE AS PRINTED ON THE TEST STRIP VIAL. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SERIOUS SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED INACCURACY BEGAN.