At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.Dhrs (device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs 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 caregiver reported that the customer¿s adc freestyle libre 2 sensor did not alarm when glucose readings of 80 mg/dl and 40 mg/dl were obtained.Consequently, the customer experienced symptoms of sweating, seizures, and a loss of consciousness and was unable to self-treat.The customer¿s wife treated him with glucagon, milk, and cracker, and no further information was provided.There was no report of death or permanent injury associated with this event.
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