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.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 reported product is not expected to be returned as reporter indicated the device was discarded.Therefore, no further investigations planned.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
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A customer reported experiencing a skin reaction at the site of the freestyle libre 2 sensor, with symptoms of pain, redness, inflammation, abscess, and purulence.The customer had contact with a healthcare professional.It was determined that customer had sepsis, and was given antibiotics, and an abscess at the site was excised.There was no report of death or permanent injury associated with this event.
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