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)
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Event Date 12/12/2023 |
Event Type
Injury
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Manufacturer Narrative
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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 for this complaint.An extended investigation has been performed for the reported complaint.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.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.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.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 while wearing the adc device.The customer experienced a skin infection, red, hot, irritated at sensor site and as a result, had contact with a healthcare professional (hcp) who provided antibiotic fucidin cream as treatment for this issue.There was no report of death or permanent injury associated with this event.
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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.Therefore, the 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 while wearing the adc device.The customer experienced a skin infection, red, hot, irritated at sensor site and as a result, had contact with a healthcare professional (hcp) who provided antibiotic fucidin cream as treatment for this issue.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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