Abbott diabetes care received a medwatch report which reported the following information: a customer reported a skin reaction at the site of the adc device.The customer reported they had developed a rash, and went to dermatologist to have skin biopsy done.The customer was contacted and reported that in addition to rash, they experienced itching, blisters, and the rash spread.The customer was prescribed fluocinonide cream for treatment, on (b)(6) 2022.There was no report of death or permanent injury 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 demonstrated the continued effectiveness of the established sterilization process for libre sensor kits.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 completed for the reported complaint and freestyle libre sensors, and there were no adverse trends that indicate any potential 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.All pertinent information available to abbott diabetes care has been submitted.
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