Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Skin Infection (4544)
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Event Date 06/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that 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.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates 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.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered is the date reported as "(b)(6) 2022" all pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A complaint was received regarding skin irritation while wearing the adc device and experiencing pus and drainage at the sensor site.Hcp contact was made in (b)(6) 2022, and disinfectant and antibiotic cream was prescribed for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been retuned and investigated.Visual inspection was performed, and no issues were observed on sensor patch.No issues were observed with the adhesive.No malfunction or product deficiency was identified.This issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A complaint was received regarding skin irritation while wearing the adc device and experiencing pus and drainage at the sensor site.Hcp contact was made in (b)(6) 2022, and disinfectant and antibiotic cream was prescribed for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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