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); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
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Event Date 11/30/2023 |
Event Type
Injury
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Event Description
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An adverse skin reaction was reported with wear of the adc device.Customer experienced symptoms described as redness, swelling, and an infection at the sensor site and had contact with a healthcare professional who prescribed antibiotics for treatment (cefaclor/375mg).There was no report of death or permanent impairment associated with this event.
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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 date of event is unknown.The date entered in section b3 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 wear of the adc device.Customer experienced symptoms described as redness, swelling, and an infection at the sensor site and had contact with a healthcare professional who prescribed antibiotics for treatment (cefaclor/375mg).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.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dose audit reports were reviewed and demonstrated 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.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.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)has been returned and investigated.No physical damage was observed on the returned sensor patch and no issues were observed with the returned sensor adhesive.No malfunction or product deficiency has been 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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An adverse skin reaction was reported with wear of the adc device.Customer experienced symptoms described as redness, swelling, and an infection at the sensor site and had contact with a healthcare professional who prescribed antibiotics for treatment (cefaclor/375mg).There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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