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 date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered 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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Abbott diabetes care received an (b)(6) declaration which reported the following information: a pediatrician reported that a patient who is using the freestyle libre 2 sensor has experienced recurrent contact dermatitis at sensor site, despite use of barrier preparations.The patient experiences redness, and itching, and sensors have to be removed prematurely.The pediatrician has had patient stop sensor usage, provided unspecified localized treatment to inflamed sensor site, and refer patient to a dermatologist.It was also noted that the pediatrician suspected the sensor began to provide inaccurate readings when the skin reaction worsened; however, there was no report of adverse event or third-party intervention for reported reading issue.There was no report of death or permanent injury associated with this event.
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