At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing date 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 caregiver reported via email that the adc freestyle libre 2 sensor detached after 1 day of wear due to exposure to moisture.On (b)(6) 2020, because of the sensor detaching, the customer had a seizure and lost consciousness.Emergency services were called, and a blood glucose of 26 mg/dl was obtained on the hcp meter and the customer as provided sugar by the caregiver.The customer was taken the emergency room and was further treated with a glucose infusion and diagnosed with hypoglycemia.There was no report of death or permanent injury associated with this event.
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