Description of Event or Problem · 1
ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN APPROXIMATELY 3 WEEKS PRIOR TO HER CONTACTING LFS. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿20-30 POINTS HIGHER¿ WITH THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT REPORTED THAT SHE DOES NOT TAKE ANY MEDICATION FOR DIABETES, AND THAT AS ADVISED BY HER DOCTOR, SHE DOES NOT CONSUME FOOD UNLESS HER RESULTS ARE BELOW A CERTAIN AMOUNT. THE PATIENT ALLEGES THAT A FEW MINUTES AFTER THE METER ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF ¿SHAKY, SWEATY AND FEELING WEAK¿. IN RESPONSE TO THE SYMPTOMS, SHE REQUIRED HER HUSBAND TO TREAT HER WITH ¿15 CARBS OF SIMPLE SUGAR¿. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, AND THAT THE PATIENT¿S TEST STRIPS HAD BEEN STORED CORRECTLY, WERE WITHIN EXPIRY DATE. THE CSR WALKED THE REPORTER THROUGH A RETEST AND THE CONTROL SOLUTION TEST WAS IN RANGE. 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.