Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Blister (4537)
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Event Date 02/01/2022 |
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 exact date that the incident occurred is unknown.The date entered is based on the customer report of "early (b)(6) 2022".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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A customer reported experiencing a skin reaction while wearing the adc device, with symptoms of an insertion site allergy and ¿water bubbles under the sensor¿.The customer had contact with a healthcare professional who prescribed betagalen (betamethasone-topical corticosteroid) for treatment.No further information was provided.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.Extended investigation has been performed for the reported complaint and 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.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.Dhrs (device history record) for the freestyle libre sensor kit were reviewed, and the dhrs showed the freestyle libre sensor kit passed all tests prior to release.Section h4 (device mfg date) were updated based on extended investigation.If the product is returned, a physical investigation will be performed and a follow-up report submitted.
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Event Description
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A customer reported experiencing a skin reaction while wearing the adc device, with symptoms of an insertion site allergy and ¿water bubbles under the sensor¿.The customer had contact with a healthcare professional who prescribed betagalen (betamethasone-topical corticosteroid) for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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