Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Skin Infection (4544); Swelling/ Edema (4577)
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Event Date 04/01/2023 |
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 in section b3 is based on the customer report of "patient does not remember the exact date only indicated it to be (b)(6)".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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An adverse skin reaction was reported with the wear of the adc device.The customer experienced symptoms described as "infection site infection" and felt " punches, swollen and hot legs" and had contact with the healthcare provider who prescribed antibiotics for treatment.There was no report of death or permanent impairment associated with this event.
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Event Description
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An adverse skin reaction was reported with the wear of the adc device.The customer experienced symptoms described as "infection site infection" and felt " punches, swollen and hot legs" and had contact with the healthcare provider who prescribed antibiotics for 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.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.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 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.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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Search Alerts/Recalls
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