Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 AT APPROXIMATELY NOON. THE PATIENT REPORTED TESTING ON THE SUBJECT METER AND OBSERVED VALUES OF ¿58, 60 MG/DL¿ WHICH SHE FELT WAS INACCURATELY LOW AS COMPARED TO HOW SHE FELT. IT IS NOT KNOWN WHAT RANGE THE PATIENT CONSIDERS TO BE NORMAL. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION AND DIET/EXERCISE AND SHE REPORTED THAT IN RESPONSE TO THE LOW READING AT 6PM THAT SAME DAY, SHE CONSUMED MORE FOOD/DRINK. THE PATIENT CLAIMED THAT 4-5 HOURS LATER, SHE DEVELOPED SYMPTOMS OF ¿SWEATING AND HEART RACING¿ BUT DESPITE HER SYMPTOMS, SHE DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION, IT IS NOT KNOWN IF QUALITY CONTROL TESTING WAS PERFORMED. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.