A customer reported experiencing skin irritation related to the use of a freestyle libre sensor.The customer reported that after 5 days they experienced itching, red skin, blistering.The customer reported having contact with a health care provider in (b)(6) 2017 (date was not specified) and being prescribed a cortisone ointment and being diagnosed with allergic skin reaction.The customer indicated that after removing the sensor and applying the cortisone ointment the area was "ok." no additional treatment was reported.There was no report of death or permanent impairment as a result of the event.
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No product has been returned.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 and environmental monitoring reports were reviewed for issues relating to sterility of the product.The sensor component has no impact on product sterility and therefore, sensor components dhrs were not reviewed.Sensor kit dhrs have been reviewed to assess the manufacturing process, which includes the application of the adhesive to the puck.A dhr (device history review) for the freestyle libre sensor kit was reviewed and the dhr showed the freestyle libre sensor kit passed all tests prior to release.Clinical data was reviewed and confirmed that libre sensor continue to be safe, effective, and perform as intended in the field.Dose audit reports were reviewed and demonstrates 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.A tripped trend review was completed for the reported complaint and fs libre sensor, no trips were observed.If the product is returned, the case will be re-opened and a physical investigation will be performed.
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A customer reported experiencing skin irritation related to the use of a freestyle libre sensor.The customer reported that after 5 days they experienced itching, red skin, blistering.The customer reported having contact with a health care provider in august 2017 (date was not specified) and being prescribed a cortisone ointment and being diagnosed with allergic skin reaction.The customer indicated that after removing the sensor and applying the cortisone ointment the area was "ok." no additional treatment was reported.There was no report of death or permanent impairment as a result of the event.
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