This is an initial final report.This issue does not meet reportability criteria, however it is being reported to fda as the complaint was received via medwatch report.If product is returned, this case will be re-opened, an investigation will be conducted, and a follow-up report will be submitted after all investigation activities are complete.The device mfg 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 notice of an fda medwatch report submitted by a physician which reported the following: a clinical study participant developed severe local contact dermatitis, with symptoms described as "pruritic rash", while wearing the adc freestyle libre pro sensor.Additionally, it was reported that the patient had multiple blinded recordings of hypoglycemia, which were later reported to be asymptomatic.It was further reported that the customer removed the sensor prematurely and self-treated with neosporin ointment.There was no report of third-party treatment or intervention.Based on the information received, there was no report of serious injury associated with this event.
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