Description of Event or Problem · 1
ON (B)(6) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6), ALLEGING THAT HER ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER ONETOUCH METER. THE PATIENT WAS UNABLE TO PROVIDE ANY READINGS OBTAINED FROM THE SUBJECT DEVICE OR THE OTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON AN UNSPECIFIED DATE/TIME WHEN SHE FIRST OBTAINED THE METER. IT IS NOT KNOWN WHAT RANGE THE PATIENT CONSIDERS TO BE NORMAL. THE PATIENT MANAGES HER DIABETES WITH AN UNKNOWN TYPE OF RAPID (FAST ACTING) INSULIN AND REPORTED THAT IN RESPONSE TO THE ALLEGED HIGH READING SHE DID NOT MAKE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE, ALTHOUGH SELF-ADMINISTERED ½ UNIT MORE OF INSULIN ON AN UNKNOWN DATE/TIME. THE PATIENT REPORTED ANOTHER DEVICE WAS USED FOR TESTING BUT DID NOT RECALL THE VALUE OBTAINED OR THE DATE/TIME THE TEST WAS PERFORMED. THE CCA WAS UNABLE TO PERFORM TROUBLESHOOTING SINCE THE PATIENT DID NOT HAVE ANY OF THE PRODUCTS ANY LONGER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.