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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A customer reported a sensor error message with the adc device.The customer reported that due to this issue the customer developed symptoms of weakness, trembling, fall, and seizure.However, the customer did not report of treatment.There was no further information provided.There was no report of death or permanent injury associated with this event.
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