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 A CALIBRATED LABORATORY DEVICE. 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 ¿6.9 MMOL/L¿ COMPARED TO ¿3.4 MMOL/L¿ OBTAINED ON THE LABORATORY DEVICE. 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. IT WAS NOTED THAT THE PATIENT HAD USED AN INCORRECT TESTING METHOD, USING A BORIC ACID SOLUTION FOR CLEANING THE SKIN AREA. 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.