On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra2 meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation, since the patient was unable to be reached by phone to obtain additional information.The patient reported that the alleged meter inaccuracy began on the morning of (b)(6) 2020.The patient claimed he tested his blood glucose with the subject meter and obtained readings of "236, 269 and 93 mg/dl" at 8:00 am, 9:00 am, and 9:01 am respectively.The patient stated that he does not take any medication to manage his diabetes and denied making any changes to his usual diabetes management routine in response to the alleged inaccurate results.The patient reported that after 9:00 am on september 16, 2020, he developed symptoms of "anxiety, clammy and probably raised blood pressure." the patient denied receiving medical treatment.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca documented that the same approved sample site was used for testing and that the correct testing process was being followed.The cca noted the patient did not have control solution available to perform a quality control test.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.
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