Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Purulent Discharge (1812); Pain (1994); Skin Infection (4544)
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Event Date 03/06/2024 |
Event Type
Injury
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Event Description
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An adverse skin reaction was reported with wear of the abbott diabetes care (adc) device.A customer reported experiencing symptoms described as "pain, pus, and abscess" while wearing the adc device.The customer had contact with a healthcare professional (hcp) on (b)(6) 2024 and was prescribed augmentin (antibiotics) however after a few days (unspecified time lapse), the site did not improve.On (b)(6) 2024, the customer had hcp contact again and the abscess was drained 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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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered in section h4 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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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.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 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 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.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 abbott diabetes care (adc) device.A customer reported experiencing symptoms described as "pain, pus, and abscess" while wearing the adc device.The customer had contact with a healthcare professional (hcp) on 2-mar-24 and was prescribed augmentin (antibiotics) however after a few days (unspecified time lapse), the site did not improve.On 6-mar-2024, the customer had hcp contact again and the abscess was drained 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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