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 review) 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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The customer reported a "scan error" message with the adc freestyle libre 2 sensor, when scanning with the reader.The customer subsequently experienced symptoms of sweating, tachycardia, and "no control over body".The customer was treated with 15 grams of sugar by a third-party.There was no report of death or permanent injury associated with this event.
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