On (b)(6) 2021, the reporter of the lay user/patient contacted lifescan (lfs) usa, alleging that her mother¿s onetouch verio reflect meter was displaying the ¿error 2¿ message after applying a blood sample.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The reporter alleged that the error message began to appear on (b)(6) 2021, at 3 pm.The patient manages her diabetes with oral medication (metformin ¿ dose unspecified) and the reporter claimed that she did not make any changes to her usual diabetes management regimen in response to the alleged issue.The reporter stated that her mother got sick because she was unable to test and therefore developed symptoms of ¿dizziness, weakness and pale¿ between 3 and 4 pm, after the issue occurred.The reporter informed the cca that her mother was taken to the emergency room (er) where they obtained a blood glucose reading of ¿52 mg/dl¿ on a clinic meter.The reporter advised that her mother received hcp treatment, but she could not remember what kind of treatment.At the time of troubleshooting, the customer care agent (cca) noted the subject meter was not being used for the first time.The strips had not been open longer than the discard date, had not expired, and had been stored correctly.The patient had followed the correct testing process.The cca walked the patient through resolving the alleged issue however the issue remained unsolved.A replacement meter has been sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began.
|