Description of Event or Problem · 1
ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS AND INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2017 AT 10:30 AM. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿323, 230, 236, 208 AND 291 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 ALSO REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿174, 115, 131, 160, 179, 323, 230, 236, 208 AND 291 MG/DL¿ WITH THE SUBJECT METER, PERFORMED MORE THAN 20 MINUTES APART. THE TIME DIFFERENCE BETWEEN THE RESULTS EXCEEDS LFS¿ CRITERIA FOR A VALID COMPARISON. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER). THE PATIENT STATED THAT SHE TOOK ACTION OF CONSUMING LESS FOOD AND DRINK FROM WHEN THE ALLEGED ISSUE BEGAN UNTIL CONTACTING LFS. THE PATIENT INFORMED THE CSR THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE STARTED SHE BECAME ¿DROWSY.¿ THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR NOTED THAT THE PATIENT WAS TESTING WITH TEST STRIPS THAT HAD EXPIRED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER OBTAINING ALLEGED INACCURATE RESULTS WITH THE SUBJECT METER.