Model Number 71940-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Pain (1994); Skin Infection (4544); Swelling/ Edema (4577)
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Event Date 03/06/2021 |
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 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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It was reported customer experienced a skin reaction while wearing an adc freestyle libre sensor and experienced symptoms described as pain, swelling, and an abscess at the sensor site.Customer had contact with a healthcare professional and received fucidine 2% topical antibiotic 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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Sensor (b)(6) has been returned and investigated.A visual inspection performed on the sensor patch, sensor adhesive, and sensor sharp with no issues observed.The sensor plug was observed properly seated.Visual inspection was performed on the returned sensor plug and no failure modes were observed.The sensor kit has not been returned therefore further investigation has not been performed.No malfunction or product deficiency has been identified.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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It was reported customer experienced a skin reaction while wearing an adc freestyle libre sensor and experienced symptoms described as pain, swelling, and an abscess at the sensor site.Customer had contact with a healthcare professional and received fucidine 2% topical antibiotic 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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