An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dhrs (device history record) for the libre sensor kit were reviewed and the dhrs showed the libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.The exact date of event is unknown.The date entered in is per the customer's report of "8 days ago." all pertinent information available to abbott diabetes care has been submitted.
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A skin reaction was reported with the freestyle libre sensor.The customer experienced symptoms described as "redness, burning, and itching" at the sensor site and had contact with a healthcare provider who prescribed betamethasone 0.05% ointment and vaseline for treatment.There was no report of death or permanent injury associated with this event.
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