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 and sensor kit were reviewed, and the dhrs showed the 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 customer reported a low reading with the adc device.The customer self-treated with sugars, but developed symptoms of sweating, weakness, and excessive thirst.The customer had contact with a healthcare professional who diagnosed customer with hyperglycemia and provided unspecified treatment, which customer thinks was insulin (dose/type unknown).There was no report of death or permanent injury associated with this event.
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