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.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 freestyle libre sensor and freestyle libre sensor kit were reviewed, and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Shelf life studies, product monitoring, and dose audits were performed during product development and on market performance continues to be monitored at adc.If the product is returned, a physical investigation will be performed and a follow-up report submitted.N/a was selected as it is unknown if the user was using android, ios, or a fs libre reader with the fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.
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A customer reported a skin reaction at the site of the adc device, with symptoms of inflammation, swelling, and purulence.The customer had contact with a healthcare professional who prescribed antibiotics for treatment.There was no report of death or permanent injury associated with this event.
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