Description of Event or Problem · 1
ON (B)(6) 2017, THE PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH SELECT SIMPLE METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THEY FIRST BECAME AWARE OF THE METER ISSUE ON THE MORNING OF (B)(6) 2017, REPORTING THAT THEY OBTAINED INACCURATE HIGH RESULTS OF ¿5.4 ¿ 7.1 MMOL/L¿. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT STATED THAT THEY MANAGE THEIR DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE, AND THAT IN RESPONSE TO THE ALLEGED HIGH READING, THEY INCREASED THE NORMAL DOSE OF MEDICATION, TAKING 3 METFORMIN TABLETS PER DAY, INSTEAD OF THE NORMAL 1-2 TABLETS. THE PATIENT REPORTED THAT AFTER TAKING THE INCREASED MEDICATION FOR FOUR DAYS, THEY DEVELOPED SYMPTOMS OF ¿WEAK, SWEATY AND VERTIGO¿. IN RESPONSE TO THE SYMPTOMS THEY STOPPED THE EXTRA MEDICATION AND THE SYMPTOMS RESOLVED. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE, AND THAT THE PATIENT¿S TEST STRIPS HAD BEEN STORED CORRECTLY, WERE WITHIN EXPIRY DATE. THE CSR NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.