Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Pain (1994); Skin Infection (4544)
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Event Date 02/16/2024 |
Event Type
Injury
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Manufacturer Narrative
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The reported product is not expected to be returned as reporter indicated the device was discarded.Therefore, no further investigations planned.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported a skin reaction with wear of the adc device.The customer reported experiencing a skin infection with symptoms described as redness, "discharge," irritation, and pain had initial contact with a healthcare professional who prescribed amoxicillin for treatment.Approximately a week later, the customer had secondary contact with a hcp where their previous prescription dosage of amoxicillin was increased.The customer indicated they were hospitalized during the secondary hcp contact but stated the hospital stay is not due to an adc device.No further information was provided.There was no report of death or permanent injury 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 incident are the adhesive, including the adhesive irritating the user¿s skin, or misuse, including improper site selection and repeatedly using the same application site to place the sensor.These conditions are mitigated through the freestyle product labelling.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.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 fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and 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.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported a skin reaction with wear of the adc device.The customer reported experiencing a skin infection with symptoms described as redness, "discharge," irritation, and pain had initial contact with a healthcare professional who prescribed amoxicillin for treatment.Approximately a week later, the customer had secondary contact with a hcp where their previous prescription dosage of amoxicillin was increased.The customer indicated they were hospitalized during the secondary hcp contact but stated the hospital stay is not due to an adc device.No further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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