Description of Event or Problem · 1
ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA 2 METER READ INACCURATELY HIGH IN COMPARISON TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN SOMETIME IN (B)(6) 2016. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE RESULTS OF ¿424, 233, 196 AND 255 MG/DL¿ WITH THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT INFORMED THE CSR THAT HE MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER) AND DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE AS A RESULT OF THE ALLEGED ISSUE. ON AN UNKNOWN TIME/DATE AFTER THE ALLEGED PRODUCT ISSUE BEGAN THE PATIENT REPORTED THAT HE DEVELOPED SYMPTOMS OF ¿SWEATING AND FEELING HUNGRY¿. HE REPORTED THAT IN RESPONSE TO THE ALLEGED SYMPTOMS HE VISITED THE DOCTORS OFFICE, IT IS UNKNOWN IF ANY TREATMENT WAS RECEIVED. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THE TEST STRIPS HAD NOT EXPIRED, BEEN OPEN LONGER THAN THE DISCARD DATE AND HAD BEEN STORED CORRECTLY (PER OWNER¿S BOOKLET RECOMMENDATION). THE CSR NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. THE PRODUCTS WERE REQUESTED BACK FOR EVALUATION AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.