Model Number 71940-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Bacterial Infection (1735)
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Event Date 02/02/2020 |
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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The customer reported experiencing a skin reaction while wearing an adc freestyle libre sensor and experienced cellulitis on the arm.The customer went to the hospital where he was hospitalized for 3 days, administered intravenous antibiotics and prescribed bactroban ointment 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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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.This also serves as a correction report.Section date of event was incorrectly documented in initial report.Correction has been made.
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Event Description
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The customer reported experiencing a skin reaction while wearing an adc freestyle libre sensor and experienced cellulitis on the arm.The customer went to the hospital where he was hospitalized for 3 days, administered intravenous antibiotics and prescribed bactroban ointment 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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