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 "replace sensor" message with the adc freestyle libre 2 sensor, on the 8th day of wear.The customer was unable to obtain further readings, and subsequently experienced symptoms of fatigue, shortness of breath, and blurred vision.The customer's caregiver treated the customer with an unspecified dose of humalog (insulin lispro).There was no report of death or permanent injury associated with this event.
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