Description of Event or Problem · 1
ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH HER ONETOUCH LANCING DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2012 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HER BLOOD GLUCOSE 3X DAILY. THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT CONTINUED TO FOLLOW HER USUAL DIABETES MANAGEMENT ROUTINE. A WEEK AFTER TRYING TO USE THE SUBJECT LANCING DEVICE, THE PATIENT CLAIMS SHE DEVELOPED A BUMP ON HER FINGER WHICH SHE THOUGHT WAS A WART. THE PATIENT REPORTEDLY VISITED HER PHYSICIAN'S OFFICE AND REQUESTED MEDICATION FOR THE WART; HOWEVER, THE PHYSICIAN ADVISED HER IT WAS AN INFECTION AND NOT A WART. THE PATIENT ALLEGED THE PHYSICIAN SQUEEZED "GREEN PUS" FROM THE SITE AND ADMINISTERED THE PATIENT AN ANTIBIOTIC SHOT. THE PATIENT ALLEGED SHE WAS NOT PROPERLY CLEANING THE PUNCTURE SITE AT THE TIME OF THE REPORTED ISSUE AND DOES NOT NORMALLY HEAL QUICKLY AFTER A SORE. THE PATIENT CONFIRMED SHE IS CURRENTLY CLEANING THE PUNCTURE SITE PROPERLY AND HAS CONTINUED USING THE SUBJECT LANCING DEVICE. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED AN INFECTION AFTER USING THE LFS PRODUCT AND ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.