Description of Event or Problem · 1
ON (B)(6) 2019, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2019 SHE OBTAINED A RESULT OF "166MG/DL" ON THE SUBJECT METER, WHICH SHE FELT WAS INACCURATELY HIGH IN COMPARISON TO A RESULT OF "140MG/DL" OBTAINED ON A CONTOUR NEXT METER, WITHIN 30 MINUTES OF EACH OTHER. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRED. THERE CAN BE NO PRESUMPTION AS TO WHICH METER'S READING IS ERRONEOUS AS THE COMPARISON IS NOT MADE TO A CALIBRATED REFERENCE METHOD. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP AND DID NOT SPECIFY MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT AN UNSPECIFIED TIME AFTER THE ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF "A LITTLE TIRED AND SWEATY" AND SELF-TREATED BY "DRINKING SOME JUICE". DURING TROUBLESHOOTING THE CSA NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND AN APPROVED SAMPLE SITE HAD BEEN USED. REPLACEMENT PRODUCTS WERE SENT TO THE REPORTER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS' CRITERIA FOR A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.