The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle 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.N/a was selected for pma/510k as it is unknown if the user was using android, ios, or a reader with the fs libre 3 sensor.
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An error message was reported with the adc device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced "a loss of consciousness, sweating, fast heartbeat, and felt hot." the customer was treated with "iv d-10 or d-50" by paramedics.There was no report of death or permanent impairment associated with this event.
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