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 kit were reviewed, and the dhrs showed the 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 the freestyle libre 2 sensor detached on day of application.The customer was unable to monitor glucose and subsequently experienced sweating, seizure, and loss of consciousness.The customer received unspecified treatment and insulin from a healthcare professional.There was no report of death or permanent injury associated with this event.
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