Model Number 72081-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Bruise/Contusion (1754); Device Embedded In Tissue or Plaque (3165)
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Event Date 11/21/2022 |
Event Type
Injury
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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.N/a was selected as it is unknown if the user was using android, ios, or a reader with the fs libre 3 sensor.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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A customer reported the adc device "needle feedlement stayed in arm" and remained in the customer's skin.The customer reported experiencing "hard little naught where the needle was and an 8-inch bruise" and was unable to self-treat.Customer had contact with a healthcare professional where an x-ray and ultrasound.In addition, hcp obtained a laboratory result of 123 mg/dl.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.No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 reported the adc device "needle feedlement stayed in arm" and remained in the customer's skin.The customer reported experiencing "hard little naught where the needle was and an 8-inch bruise" and was unable to self-treat.Customer had contact with a healthcare professional where an x-ray and ultrasound.In addition, hcp obtained a laboratory result of 123 mg/dl.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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