A caller reported a high reading issue with the adc device.The customer reported an unspecified high sensor reading, and self-treating with insulin without capillary comparison.The customer subsequently lost consciousness, and fell.The customer's wife assisted customer after fall, but no other treatment was reported.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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre 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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