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 ULTRA METER WAS DISPLAYING AN UNKNOWN ERROR MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE REPORTER CLAIMED THAT ON AN UNKNOWN DATE/TIME THE PATIENT ATTEMPTED TO CHECK HER BLOOD GLUCOSE AND WAS UNABLE TO DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH AN UNKNOWN TYPE/DOSE OF INSULIN AND IS A SELF ADJUSTER. THE PATIENT REPORTEDLY INCREASED HER DOSE OF MEDICATION BY AN UNKNOWN AMOUNT IN RESPONSE TO THE ALLEGED ISSUE. SHE CLAIMED THAT AT AN UNSPECIFIED DATE/TIME THE PATIENT EXPERIENCED "HIGH SUGAR SYMPTOMS" BUT DID NOT SPECIFY WHAT THE SYMPTOMS WERE. DESPITE HER SYMPTOMS, NO MEDICAL INTERVENTION HAD TAKEN PLACE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT AVAILABLE FOR TROUBLESHOOTING AS THE PATIENT/REPORTER HAD ALREADY DISPOSED OF IT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THERE IS A LACK OF DETAILS REGARDING THIS COMPLAINT, THE COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED UNKNOWN HYPERGLYCEMIC SYMPTOMS AFTER THE ALLEGED ISSUE OCCURRED.