Model Number 71992-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Erythema (1840); Itching Sensation (1943); Skin Irritation (2076)
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Event Date 07/27/2020 |
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.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 kit were reviewed and the dhrs showed the 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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A caller reported a customer had a skin reaction while wearing the adc freestyle libre 2 sensor and experienced "slight redness, itching, and wetting" at the sensor site.Hcp contact was made and unknown treatment 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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Visual inspection has been performed on the returned sensor patch (serial number (b)(4)) and no physical damage was observed.Adhesive was not returned.Extended investigation was performed and previously submitted in the initial mdr report.No malfunction or product deficiency was identified.
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Event Description
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A caller reported a customer had a skin reaction while wearing the adc freestyle libre 2 sensor and experienced "slight redness, itching, and wetting" at the sensor site.Hcp contact was made and unknown treatment 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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