Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Skin Infection (4544); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
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Event Date 01/01/2024 |
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.The product has been requested back for an investigation.At this time product has not yet 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.The device history records (dhrs) for the freestyle libre sensor kit was reviewed and the dhrs showed the sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrated 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 with wear of the adc device.Customer experienced infection, inflammation, swelling, redness, pain at the sensor site and had contact with a healthcare professional who cut the sensor insertion site, "disinfection, balm and covered" 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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Sensor (b)(6) has been returned and investigated.No physical damage was observed on the sensor patch.Adhesive has not been returned.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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An adverse skin reaction was reported with wear of the adc device.Customer experienced infection, inflammation, swelling, redness, pain at the sensor site and had contact with a healthcare professional who cut the sensor insertion site, "disinfection, balm and covered" for 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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