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); Swelling/ Edema (4577)
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Event Date 08/28/2022 |
Event Type
Injury
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Event Description
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A customer reported a skin reaction with the adc device.The customer indicated developing infection-like symptoms at the sensor site including swelling, tenderness, and pus.The customer was seen by a healthcare professional who prescribed antibiotics for treatment.
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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 record) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and 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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Manufacturer Narrative
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Sensor (b)(6).Has been returned and investigated.No physical damage was observed on the sensor patch.Observed adhesive was not returned.No malfunction or product deficiency was identified.Therefore, the 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 customer reported a skin reaction with the adc device.The customer indicated developing infection-like symptoms at the sensor site including swelling, tenderness, and pus.The customer was seen by a healthcare professional who prescribed antibiotics for treatment.
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Search Alerts/Recalls
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