At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history record) for the freestyle libre sensor kit was reviewed and the dhrs showed the freestyle 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 bent sensor tip with the adc device and reported "sensor did not penetrate skin." as a result, customer experienced symptoms described as "head sickness and transpiration problem," a seizure and reported being able to self-treat with unspecified treatment.No healthcare professional treatment was rendered for this issue.There was no report of death or permanent injury associated with this event.
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