Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Pain (1994); Burning Sensation (2146); Skin Infection (4544)
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Event Date 04/19/2022 |
Event Type
Injury
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Event Description
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A complaint was received indicating a skin irritation while wearing the adc device and experienced infection-like symptoms described as pain, redness, and burning sensation at the sensor site.Hcp contact was made on (b)(6) 2022, and the customer has been prescribed an unknown ointment 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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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.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 indicating a skin irritation while wearing the adc device and experienced infection-like symptoms described as pain, redness, and burning sensation at the sensor site.Hcp contact was made on 19apr2022, and the customer has been prescribed an unknown ointment 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) was returned and investigated.Visual inspection was performed, and no issues were observed.Visual inspection was performed on the returned adhesive and no issues were observed.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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Search Alerts/Recalls
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