At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.Dhrs (device history record) for the libre sensor and 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.N/a was selected for pma/510k as it is unknown if the user was using android, ios, or a reader with a fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.
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A bent inserter needle was reported with the adc device and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced dizziness and was unable to self-treat, requiring treatment of insulin (dose type unknown) by a health care provider.There was no report of death or permanent impairment associated with this event.
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