Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Pain (1994); Device Embedded In Tissue or Plaque (3165)
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Event Date 07/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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The reported product is not expected to be returned, as the device was reportedly discarded.A follow-up report will be submitted if product is returned or additional information is obtained.The device manufacturing 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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Event Description
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A customer reported, that the adc device sensor filament remained in skin after sensor removal.The customer reported, experiencing pain.And had contact with a healthcare provider for "removal through minor surgery".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.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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Event Description
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A customer reported that the adc device sensor filament remained in skin after sensor removal.The customer reported experiencing pain, and had contact with a healthcare provider for "removal through minor surgery".There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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