At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and 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 an alarm issue with the adc device.The customer reported that the low glucose alarm failed to trigger when customer became hypoglycemic and customer experienced chills, sweating, headache, seizure, and loss of consciousness.The customer went to hospital where a capillary result of 10 mg/dl was obtained, and the customer diagnosed with hypoglycemia.The customer was treated with 4-5 doses of glucagon injection and provided water.There was no report of death or permanent injury associated with this event.
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