Model Number 71992-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Unspecified Infection (1930); Skin Inflammation (2443)
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Event Date 10/09/2020 |
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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The customer reported a skin reaction at the site of the freestyle libre 2 sensor, with the symptom of inflammation.The customer had contact with a healthcare professional, who prescribed penicillin as 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 observed with the sensor patch.No issues were observed with the sensor adhesive.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.Additional information - section g1: (contact office first name, contact office last name, contact office phone number and contact office email) has been updated.
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Event Description
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The customer reported a skin reaction at the site of the freestyle libre 2 sensor, with the symptom of inflammation.The customer had contact with a healthcare professional, who prescribed penicillin as 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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