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.The dhrs (device history record) for the libre sensor kit were reviewed, and the dhrs showed the libre 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 customer reported that the adc device detached prematurely.The customer reported that due to this issue, they developed symptom of vomiting, and was taken to hospital.The customer was treated with insulin, potassium, and hydrating serum via iv for a diagnosis of diabetic ketoacidosis.There was no report of death or permanent injury associated with this event.
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