Description of Event or Problem · 1
ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH VERIO IQ METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT SHE FIRST BECAME AWARE OF THE ISSUE, AT 8.15 AM, ON (B)(6) 2018. THE PATIENT REPORTED THAT SHE OBTAINED ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS OF ¿244, 209, 230, 250, 281 AND 232 MG/DL¿, THE TESTS WERE PERFORMED GREATER THAN 20 MINUTES OF EACH OTHER. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH METFORMIN 750 MG, AND THAT SHE ADMINISTERED HER NORMAL DOSE. THE PATIENT REPORTED THAT 15 MINUTES PRIOR TO HER BECOMING AWARE OF THE ISSUE, SHE HAD DEVELOPED SYMPTOMS OF ¿SHAKING¿. THE PATIENT REPORTED THAT AT 9 AM ON (B)(6) 2018, IN RESPONSE TO THE SYMPTOMS, THE PATIENT ATTENDED THE DOCTOR, WHO ADMINISTERED GLUCOPHAGE TO HER AND INCREASED HER METFORMIN TO 750 MG TWICE PER DAY. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE, AND THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES. 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. THERE IS INSUFFICIENT INFORMATION TO RULE OUT THE CONTRIBUTION OF THE SUBJECT METER TO THE EVENT.