Model Number 72081-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
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Event Date 09/19/2023 |
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.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.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.The device history records (dhrs) for the freestyle libre sensor kit were reviewed and the dhrs showed the 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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Event Description
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A customer experienced a skin reaction while wearing an adc device and experienced "itching, swelling, redness and open wound" at the sensor site.Customer had contact with a healthcare professional and was prescribed an unspecified medication for treatment.No further information was reported.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer experienced a skin reaction while wearing an adc device and experienced "itching, swelling, redness and open wound" at the sensor site.The customer had contact with a healthcare professional, and it is unknown if treatment was rendered or medication was prescribed.No further information was reported.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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This serves as a correction report.Section updated as follows: b5 - describe event or problem.
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Manufacturer Narrative
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Sensor (b)(6) was returned and investigated.Visual inspection was performed, and no issues were observed.Visual inspection was performed on the returned 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 experienced a skin reaction while wearing an adc device and experienced "itching, swelling, redness and open wound" at the sensor site.The customer had contact with a healthcare professional, and it is unknown if treatment was rendered or medication was prescribed.No further information was reported.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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