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); Skin Inflammation/ Irritation (4545)
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Event Date 11/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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The customer's product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing date is unknown.The date entered 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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Event Description
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An adverse skin reaction was reported with wear of the adc device.Customer experienced an infection at the adc sensor site with symptoms described as pain, redness, purulent discharge, and an abscess requiring an initial prescription of amoxicillin (500mg, take three times daily) and ultimately an incision of the abscess by a healthcare professional.No further treatment 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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An adverse skin reaction was reported with wear of the adc device.Customer experienced an infection at the adc sensor site with symptoms described as pain, redness, purulent discharge, and an abscess requiring an initial prescription of amoxicillin (500mg, take three times daily) and ultimately an incision of the abscess by a healthcare professional.No further treatment 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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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.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.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.Clinical data was reviewed and confirmed that freestyle libre sensor continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential product related issues.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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Search Alerts/Recalls
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