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 kits 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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A customer reported that while using the freestyle libre 2 app, a sensor error message was received with the adc device.As a result, the customer became hypoglycemic with symptoms described as ¿heat,¿ sweating, and was unable to self-treat.The customer had contact with a healthcare provider who treated the customer with oral glucose for the diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
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