Description of Event or Problem · 1
ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA 2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY ISSUE BEGAN AROUND (B)(6) 2016, ALLEGING THAT SHE OBTAINED INACCURATE BLOOD GLUCOSE RESULTS OF ¿213, 314, AND 212 MG/DL¿ ON THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS FALLS WITHIN LFS¿ CRITERIA FOR PRECISION. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER), AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AS A RESULT OF THE ALLEGED ISSUE. AROUND 5-8 MINUTES AFTER THE ALLEGED INACCURACY THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿SWEATY, DIZZY AND DRAINED¿. THE PATIENT REPORTED SHE SELF-TREATED THE ALLEGED SYMPTOMS WITH CONSUMING FOOD AND/OR DRINK. DURING TROUBLESHOOTING, IT WAS ESTABLISHED THAT THE PATIENT¿S METER WAS SET TO THE CORRECT UNIT OF MEASURE. SHE DESCRIBED THE CORRECT TESTING STEPS AND THE SAMPLE WAS TAKEN FROM AN APPROVED SAMPLE SITE. THE PATIENT WAS USING THE CORRECT TEST STEPS, AND THE STRIPS HAD NOT BEEN OPEN LONGER THAN THE DISCARD DATE, HAD NOT EXPIRED, AND HAD BEEN STORED CORRECTLY. THE TEST STRIP VIAL WAS NOT NOTED TO BE CRACKED OR BROKEN. THE CSR NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. THE PRODUCTS WERE REQUESTED BACK FOR EVALUATION AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.