Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE ONETOUCH ULTRASMART METER DOES NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN THREE WEEKS PRIOR TO CONTACTING LFS. IN ADDITION TO ORAL MEDICATION (GLYCOSIDE), THE PATIENT STATED SHE ALSO MANAGES HER DIABETES WITH DIET AND/OR EXERCISE; THE PATIENT DID NOT MAKE ANY CHANGES TO HER DIABETES REGIMEN AFTER THE REPORTED POWER ISSUE OCCURRED. ACCORDING TO THE CSR¿S DOCUMENTATION, THE PATIENT DID NOT TEST HER BLOOD GLUCOSE FOR TWO WEEKS AND WITHIN THOSE TWO WEEKS (DATE/TIME NOT SPECIFIED) THE PATIENT REPORTEDLY DEVELOPED HYPERGLYCEMIC SYMPTOMS (SPECIFYING SHE FELT HOT AND WAS THIRSTY). THE PATIENT, HOWEVER, DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION AFTER THE ALLEGED ISSUE OCCURRED. PER CSR NOTES, AFTER TWO WEEKS, THE PATIENT REPORTEDLY WENT TO HER LOCAL PHARMACY AND PURCHASED A NEW ONETOUCH METER. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE PATIENT NO LONGER HAS THE SUBJECT METER; THE PATIENT HAS SINCE DISCARDED THE METER. THE CSR VERIFIED THE PATIENT WAS USING THE CORRECT TEST STRIPS AT THE TIME THE ALLEGED POWER ISSUE OCCURRED, SHE WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME, THERE WAS NO MISUSE OF THE LFS PRODUCT, AND THE SUBJECT METER¿S BATTERY DID NOT NEED TO BE REPLACED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.