Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Skin Infection (4544); Swelling/ Edema (4577)
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Event Date 04/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing date is unknown.The date entered in section h4 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 a skin reaction with the adc device.The customer experienced symptoms of redness, swelling, and pain at the sensor site and had contact with a healthcare professional who provided unspecified treatment.There was no report of death or permanent impairment associated with this event.
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Event Description
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A customer reported a skin reaction with the adc device.The customer experienced symptoms of redness, swelling, and pain at the sensor site and had contact with a healthcare professional who provided unspecified treatment.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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 kit were reviewed and the dhrs showed the 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 kits.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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Manufacturer Narrative
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Sensor (b)(6) was returned and investigated.Visual inspection was performed on the returned sensor patch and adhesive, and no issues were observed.No malfunction or product deficiency was identified.This issue is not confirmed.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 reaction with the adc device.The customer experienced symptoms of redness, swelling, and pain at the sensor site and had contact with a healthcare professional who provided unspecified treatment.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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