A signal loss issue was reported with the adc device, and the customer was unable to receive high/low glucose alarms.As a result, customer was unaware of changes in glucose levels and experienced thirst, dry mouth, and exhaustion.The customer was unable to self-treat and had contact with a healthcare professional who provided treatment of an insulin via iv for the diagnosis of hyperglycemia.No further information was provided.There was no report of death or permanent impairment associated with this event.
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"the product has been requested back for an investigation.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 device history records (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.N/a was populated as customer is using fs libre 3 sensor with fs libre reader.Fs libre 3 sensor with reader is not approved for market in us, however libre 3 is same/similar to libre 2 which is currently on market in the us.All pertinent information available to abbott diabetes care has been submitted.
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