A customer reported a low reading issue with the freestyle libre 2 sensor.The customer reported receiving unspecified lower sensor readings, which were lower than they felt.The customer was experiencing symptoms described as "feeling hot, couldn't breathe", and headache, and subsequently lost consciousness.The customer went to hospital where healthcare meter results of 33 mmol/l and 35 mmol/l were obtained.The customer received unspecified treatment for the diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.
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At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and there was no indication that the product did not meet specification.Dhrs (device history record) for the freestyle libre sensor and freestyle libre sensor kit were reviewed, and the dhrs showed the freestyle libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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