Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE' (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN APPROXIMATELY 2 WEEKS PRIOR TO CONTACTING LFS FOR ASSISTANCE (EXACT DATE/TIME NOT SPECIFIED). THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH AN UNKNOWN TYPE OF ORAL MEDICATION AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. SHE APPROXIMATELY 3 DAYS AFTER THE ALLEGED ISSUE OCCURRED WITH THE SUBJECT DEVICE, SHE DEVELOPED SYMPTOMS OF "FREQUENT URINATION." SHE CONTACTED HER DOCTOR ON (B)(6) 2013 AND WAS ADVISED BY HER DOCTOR TO MAKE AN APPOINTMENT FOR DENIED RECEIVING ANY TREATMENT FOR URINALYSIS TESTING. NO OTHER DEVICE WAS USED FOR TESTING AND NO OTHER FORM OF TREATMENT WAS ADMINISTERED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BRAND NEW. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE POWER ISSUE STILL REMAINED AFTER TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.