Description of Event or Problem · 1
ON (B)(6) 2016 THE LAY USER/PATIENT CONTACTED LIFESCAN (B)(4) ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN AT 2PM ON (B)(6). THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE READING OF 164 MG/DL ON THE SUBJECT METER AND 129 MG/DL ON A ¿(B)(6) METER¿, OBTAINED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THESE READINGS MEET LIFESCAN¿S CRITERIA FOR ACCURACY. THE PATIENT ALSO REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿170, 164 AND 151 MG/DL¿ ON THE SUBJECT METER AND ALLEGED THAT THEY WERE INACCURATELY HIGH COMPARED TO THEIR NORMAL READINGS AND/OR FEELINGS. THE PATIENT MANAGES THEIR DIABETES WITH SELF-ADJUSTED INSULIN. THE PATIENT DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE REPORTED HIGH READINGS. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿HEADACHES, DIZZINESS AND SWEATING¿ FIVE HOURS LATER. THE PATIENT REPORTED GOING TO THE EMERGENCY ROOM. THE PATIENT REPORTED THAT THEY DID NOT RECEIVE ANY TREATMENT AT THE ER BUT THEY WERE ADVISED TO CONTACT THEIR DOCTOR THE FOLLOWING MORNING. AT THE TIME OF TROUBLESHOOTING THE CCA VERIFIED THAT THE TEST STRIPS WERE STORED CORRECTLY (PER OWNER¿S BOOKLET RECOMMENDATION). THE REPORTER DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SERIOUS SYMPTOMS ASSOCIATED WITH HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.