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.Dhrs for the fs libre sensor kit were reviewed and the dhrs showed the fs 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.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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An insertion issue was reported with the freestyle libre sensor.The sensor was unable to be applied due to a bent applicator needle and customer was unable to obtain readings and monitor glucose levels.As a result, customer experienced extreme thirst, headache, and agitation and also experienced a seizure and a loss of consciousness.Customer had contact with an hcp who observed her and provided glucose gel for treatment of hypoglycemia.There was no report of death or permanent injury associated with this event.
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