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 freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and 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 high reading issue was reported with use of the adc device.The customer received unspecified high sensor scan results and as a result, customer reported experiencing symptoms described as passing out, a loss of consciousness, bleeding while wearing sensor, and was unable to self-treat.Customer had contact with a third-party (fiancé) who provided soda as treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
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