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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It was reported via webform sensor error message with the adc device.The customer's caregiver was contacted and reported that due to "scan again in 10 minutes" and "sensor ended" message, the customer became hypoglycemic with disorientation, cold sweats, and unclear speech.The customer was treated with milk with sugar and pastry.There was no report of death or permanent injury associated with this event.
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