At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and 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 kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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A customer reported a sensor error message with the adc device, and therefore did not have sensor readings.The customer became fatigued and lost consciousness.However, there was no third-party treatment reported by customer.There was no report of death or permanent injury associated with this event.
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