Abbott diabetes care (adc) received an ansm user declaration in which a healthcare professional reported a skin reaction issue with the adc device.The customer experienced symptoms of allergy and erythema at the placement site.The hcp provided the customer with tegaderm and topical corticosteroids for treatment, however it was noted that this treatment was not effective and the hcp ceased use of the device.It was also reported that customer underwent an allergy test which revealed a contact allergy to isobornyl acrylate (iboa), glue used for sensor assembly.The reporter was contacted for additional information, however, all attempts were unsuccessful.There was no report of death or permanent impairment associated with this event.
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At this time, product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint, and 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.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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors; no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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