Description of Event or Problem · 1
ON (B)(6) 2019, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH SELECT SIMPLE METER READ INACCURATELY HIGH IN COMPARISON TO HER FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ADVISED THE CSR THAT ON AN UNSPECIFIED DATE, SHE OBTAINED AN ALLEGED INACCURATELY HIGH READING ON THE SUBJECT METER COMPARED TO HER FEELINGS/NORMAL RESULTS, HOWEVER SHE WAS UNABLE TO REMEMBER THE EXACT ALLEGED INACCURATELY HIGH READING. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATIONS (DIAFORMIN AND GLIBOMET; UNSPECIFIED DOSAGES), DIET AND EXERCISE. SHE EXPLAINED THAT SHE INCREASED HER DOSE OF MEDICATIONS IN RESPONSE TO THE ALLEGED INACCURATE HIGH READING BUT WAS UNABLE TO CONFIRM THE EXACT DOSE THAT SHE TOOK. THE PATIENT ADVISED THE CSR THAT SHE ¿FELL INTO A COMA FOUR TIMES¿ AFTER THE PRODUCT ISSUE BEGAN AND EXPLAINED THAT SHE VISITED HER DOCTOR IN RESPONSE TO THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE HAD BEEN SET CORRECTLY AT THE TIME OF TESTING. THE CSR ALSO NOTED THAT THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE WITHIN EXPIRY. THE CSR WAS UNABLE TO WALK THE PATIENT THROUGH A CONTROL SOLUTION TEST AS SHE DID NOT HAVE CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON ALLEGED INACCURATE HIGH RESULTS OBTAINED WITH THE SUBJECT METER.