Model Number 71992-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Abscess (1690); Erythema (1840); Unspecified Infection (1930); Swelling (2091)
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Event Date 08/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported skin irritation while wearing the adc freestyle libre 2 sensor and experienced inflammation, swelling, redness, and warmth at the sensor site.Hcp contact was made on (b)(6) 2020, and the customer had an abscess removed and was prescribed antibiotics for treatment.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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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.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.
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Event Description
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A customer reported skin irritation while wearing the adc freestyle libre 2 sensor and experienced inflammation, swelling, redness, and warmth at the sensor site.Hcp contact was made on (b)(6) 2020, and the customer had an abscess removed and was prescribed antibiotics for treatment.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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