An adverse skin reaction was reported while wearing the adc device.The customer experienced a skin infection at sensor site and experienced symptoms described as "extreme red, wet looking, a huge rash almost like a burn with some bleeding" the customer had contact with a healthcare professional (hcp) who prescribed an unspecified treatment for this issue.There was no report of death or permanent injury associated with this event.
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.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.Dose audit reports were reviewed and demonstrated 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 freestyle libre sensor continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs 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.All pertinent information available to abbott diabetes care has been submitted.
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An adverse skin reaction was reported while wearing the adc device.The customer experienced a skin infection at sensor site and experienced symptoms described as "extreme red, wet looking, a huge rash almost like a burn with some bleeding" the customer had contact with a healthcare professional (hcp) who prescribed an unspecified treatment for this issue.There was no report of death or permanent injury associated with this event.
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