On (b)(6) 2023, the patient/lay user contacted lifescan (lfs) usa alleging that his onetouch verio meter does not turn on.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained after medical surveillance specialist reviewed the call recording.The patient alleged that the issue with the subject meter started on (b)(6) 2023, at approximately 6:00 am when he woke up ¿feeling unwell¿.The patient claimed that he tried testing his blood glucose, but the subject meter did not turn on.The patient manages his diabetes with unspecified insulin (insulin pen) and did not specify whether he made any changes in response to the alleged issue.The patient reported that he started feeling worse during the day until he ¿fell out¿ and the ambulance went to get him.The patient felt ¿incoherent¿ after this happened.The patient explained that in the hospital a blood glucose reading of ¿270 mg/dl¿ was recorded on a hospital meter and he was treated by hcp¿s with a combination of medication via iv to get his sugar down.During the call with lfs, the patient was in the hospital and did not have the subject device available to go through troubleshooting.A replacement meter was sent to the patient.This complaint is being reported because the patient claims he was unable to test his blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began.
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