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 product is not expected to be returned as the caregiver indicated they no longer had the device.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dhrs (device history review) 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.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.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 caregiver reported the customer experienced a skin reaction at the site of the adc freestyle libre 2 sensor, with the symptoms of purulent discharge at insertion site and vomiting.The customer had contact with a healthcare professional, who prescribed amoxicillin 500 mg as treatment.There was no report of death or permanent injury associated with this event.
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