Description of Event or Problem · 1
ON (B)(6) 2013, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH VERIO IQ METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE REPORTER CLAIMED THE ALLEGED ISSUE BEGAN SOMETIME IN THE MORNING ON THE SAME DAY THEY CONTACTED LFS FOR ASSISTANCE. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH FIXED DOSE INSULIN (UNKNOWN TYPE) AND DENIED MAKING ANY CHANGES TO HIS MEDICATION IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "DIZZINESS" SOME TIME THAT SAME EVENING BUT DENIED RECEIVING ANY TREATMENT FOR HIS SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS BRAND NEW. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE METER DID NOT POWER ON WITH THE POWER BUTTON, BUT DID WITH THE TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE PATIENT SYMPTOMS DID NOT CORRELATE WITH LFS'S DEFINITION SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED.