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 review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 the incident occurred 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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A customer reported receiving a ¿replace sensor¿ error message on the adc device and the customer was unable to obtain sensor scans.As a result, the customer became hyperglycemic and had a seizure, and received unknown third-party medical treatment for the reported.There was no report of death or permanent injury associated with this event.
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