Model Number 72081-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Purulent Discharge (1812); Skin Infection (4544)
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Event Date 09/23/2022 |
Event Type
Injury
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Event Description
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A customer reported a skin reaction at the site of the adc device.The customer had symptom of purulent, inflammation, and an abscess, and had contact with their healthcare provider.The abscess was excised and cleaned.There was no report of death or permanent injury associated with this event.
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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.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.It is unknown if the user was using android, ios, or a reader with the fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and 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.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.Shelf life studies and dose audits were performed during product development and on market performance continues to be monitored for this product.All monitoring processes meet adc requirements.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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Event Description
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A customer reported a skin reaction at the site of the adc device.The customer had symptom of purulent, inflammation, and an abscess, and had contact with their healthcare provider.The abscess was excised and cleaned.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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