Model Number 71992-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Inflammation (1932)
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Event Date 10/10/2020 |
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 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 customer reported a skin irritation while wearing the adc freestyle libre sensor and experienced pain, redness, inflammation, and pus at the sensor site.Hcp contact was made on (b)(6) 2020 and was prescribed cceftriaxone1 g and 100 mg doxycycline, twice daily for 10 days, for treatment.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer reported a skin irritation while wearing the adc freestyle libre sensor and experienced pain, redness, inflammation, and pus at the sensor site.Hcp contact was made on (b)(6)2020 and was prescribecceftriaxone1 g and 100 mg doxycycline, twice daily for 10 days, 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.No physical damage was observed on the sensor patch.Observed adhesive was not returned.No malfunction or product deficiency was identified.Additional information: section d3 and section g1 (contact office first name, contact office last name, contact office phone number and contact office email) have been updated to (b)(6).This serves as a correctional report as sensor serial number was incorrectly documented in section h10 (addtl mfg narrative).Sensor serial number was updated from to(b)(6)to (b)(6).
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Event Description
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A customer reported a skin irritation while wearing the adc freestyle libre sensor and experienced pain, redness, inflammation, and pus at the sensor site.Hcp contact was made on (b)(6)2020 and was prescribecceftriaxone1 g and 100 mg doxycycline, twice daily for 10 days, 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.No physical damage was observed on the sensor patch.Observed adhesive was not returned.No malfunction or product deficiency was identified.Additional information: section d3 and section g1 (contact office first name, contact office last name, contact office phone number and contact office email) have been updated to (b)(6).
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Search Alerts/Recalls
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