Model Number 71992-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Unspecified Infection (1930)
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Event Date 11/03/2020 |
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 skin reaction was reported with the adc freestyle libre sensor.The customer experienced a symptom of infection at the sensor site and had contact with a healthcare provider who prescribed unspecified 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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Sensor (b)(6) was returned and investigated.No physical damage was observed on the sensor patch.The adhesive was returned and no issue were observed.Visual inspection was performed on the sensor sharp and no issues were observed.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) have been updated to (b)(6).
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Event Description
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A skin reaction was reported with the adc freestyle libre sensor.The customer experienced a symptom of infection at the sensor site and had contact with a healthcare provider who prescribed unspecified 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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