On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) (b)(4), alleging that his onetouch select simple meter would not power on.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the alleged meter power issue began on (b)(6) 2018 at 10 am.The patient informed the csr that he manages his diabetes with 45 units of nph insulin and metformin (dose unspecified) twice daily and reported continuing with his usual diabetes management routine after the power issue began.The patient reported that after 15 days of the alleged issue starting, he developed a symptom of ¿headache¿.The patient also reported going to the emergency room (er) on (b)(6) 2018 at 8 am and had his blood glucose measured with the er meter and obtained a result of 620 mg/dl at 9 am.The patient reported receiving iv fluids as treatment.At the time of troubleshooting, the csr noted the subject meter was not being used for the first time and there was no indication of misuse to the device.The csr confirmed the correct test strips were being used for testing and based on the information provided, the batteries did not need to be replaced.The alleged product issue was not resolved with troubleshooting.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after he was unable to test his blood glucose with the subject meter due to the alleged power issue.
|