A low readings issue was reported with the adc device.The customer received low sensor scan results, and due to this, self-treated with sugar.The customer reported that they subsequently experienced "severe itching of the soles of the feet", increased sweating, dry mouth, increased thirst, and a seizure.However, the customer reported they were able to self-treat with insulin (dose/type unknown).There was no report of death or permanent impairment 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 determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the 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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