On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) united states, alleging that their onetouch verio flex meter did not power on.The complaint was classified based on the customer care agent (cca) documentation.It was not reported when the alleged power issue began.The patient manages their diabetes with insulin (sliding scale).It was not reported what action the patient took regarding their usual diabetes management regimen when they were unable to measure their blood glucose due to the alleged issue.The patient reported that on (b)(6) 2022, after the alleged issue began, they developed symptom of feeling ¿tired¿ and attended the hospital for a pre-op examination where a blood glucose reading of ¿519 mg/dl¿ was obtained on the hospital meter.The patient was treated with insulin and hospitalized for 3 days.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time and there was no indication of misuse to the device.The cca noted the meter would power on manually when the power button was pressed and when a new test strip was inserted.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute high blood glucose excursion after the alleged meter issue began.The subject meter could not be ruled out as a cause or contributor to the event.
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