On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra 2 meter was testing in settings mode.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the meter issue began around (b)(6) 2019.She reported that she manages her diabetes with oral medication metformin 500 mg, diet and exercise and made no changes to her normal diabetes management regimen in response to the alleged issue.The patient alleges on an unknown date/time after the product issue began, she developed symptoms of "blurry vision and tiredness".There is no evidence the patient required or received any treatment for the alleged symptoms, other than taking her normal medication.During troubleshooting the csr noted this was not the first time the product was being used.The csr walked through a retest with the patient and the issue was not resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms that may be 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.
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