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 replace sensor error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced nausea, a loss of consciousness and was able to self-treat with 6 units of long-acting insulin, toujeo.Customer was transported to a hospital by ambulance and was hospitalized from (b)(6) 2023 to (b)(6) 2023 with diabetic ketoacidosis, no treatment was reported.There was no report of death or permanent impairment associated with this event.
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