Is 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 error message with the adc device, and was therefore unable to obtain sensor readings.The customer was dizzy and experiencing dry mouth, and went to company's health center.A capillary result of 21.9 mmol/l was obtained, and the customer treated with insulin (dose/type unknown).There was no report of death or permanent injury associated with this event.
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