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 caregiver reported a low readings issue with the adc device.The caregiver reported low sensor readings with the customer experiencing symptoms of feeling unwell, sweating, and thirst.The customer was taken to hospital where they were provided unspecified treatment to regulate blood glucose levels.There was no report of death or permanent injury associated with this event.
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