Description of Event or Problem · 1
ON (B)(6) 2021, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) AFTER CUSTOMER CARE (CC) REVIEWED THE CALL. THE PATIENT ALLEGED THAT THE SUBJECT METER STARTED DISPLAYING INACCURATE HIGH READINGS ON (B)(6) 2021, AT 7 AM. THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿190, 194, 110 AND 91 MG/DL¿ ON THE SUBJECT METER WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT USUALLY MANAGES HIS DIABETES WITH PILLS (METFORMIN ¿ DOSE UNSPECIFIED) AND INSULIN (HUMULIN R ¿ 5 UNITS) AND HE DENIED MAKING ANY CHANGE TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. IMMEDIATELY AFTER THE PATIENT OBTAINED THE READINGS IN THE MORNING, HE STATED THAT HE FELT HIS ¿DIABETES WENT ALL THE WAY DOWN¿ AND HE FELT ¿SHAKY¿. THE PATIENT CLAIMED THAT HE TOOK ¿SOMETHING SWEET¿. NO OTHER BLOOD GLUCOSE READINGS HAVE BEEN REPORTED. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THAT THE PATIENT DID NOT HAVE A CONTROL SOLUTION AVAILABLE AT THE TIME OF THE CALL TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS HAVE BEEN 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.